Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR-CKD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03710291 |
Recruitment Status :
Recruiting
First Posted : October 18, 2018
Last Update Posted : December 9, 2020
|
Sponsor:
Tricida, Inc.
Information provided by (Responsible Party):
Tricida, Inc.
- Study Details
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Brief Summary:
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Acidosis Chronic Kidney Disease | Drug: TRC101 Drug: Placebo | Phase 3 |
This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis |
Actual Study Start Date : | November 20, 2018 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Kidney Diseases
Arm | Intervention/treatment |
---|---|
Experimental: TRC101 |
Drug: TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Other Name: Veverimer |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo comparator |
Primary Outcome Measures :
- Progression of chronic kidney disease [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
Secondary Outcome Measures :
- Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.
- Physical functioning (subjective) [ Time Frame: 18 months after randomization. ]Kidney Disease Quality of Life Physical Functioning Survey.
- Physical functioning (objective) [ Time Frame: 18 months after randomization. ]Repeated chair stand test.
- ESRD or renal death [ Time Frame: Through study completion, up to approximately 6 years. ]Time to ESRD or renal death.
- Primary outcome measure OR cardiovascular death [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
- Serum creatinine [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of a confirmed doubling of serum creatinine.
- ≥50% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of a confirmed ≥50% reduction in eGFR.
- ≥40% reduction in eGFR [ Time Frame: Through study completion, up to approximately 6 years. ]Time to first occurrence of a confirmed ≥40% reduction in eGFR.
- All-cause hospitalization [ Time Frame: Through study completion, up to approximately 6 years. ]Frequency of all-cause hospitalization.
- Cardiovascular death [ Time Frame: Through study completion, up to approximately 6 years. ]Time to cardiovascular death.
- All-cause mortality [ Time Frame: Through study completion, up to approximately 6 years. ]Time to all-cause mortality.
Other Outcome Measures:
- Safety of TRC101 [ Time Frame: Through study completion, up to approximately 6 years. ]Frequency, intensity, and relationship to study drug of adverse events and serious adverse events.
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.
- Serum bicarbonate 12 - 20 mEq/L.
- On maximum tolerated dose of ACE inhibitor and/or ARB.
Exclusion Criteria:
- Acute metabolic acidosis.
- Anticipated dialysis or kidney transplant within 6 months.
- Recent acute kidney injury.
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710291
Contacts
Contact: Clinical Operations | 415-988-5120 | valor@tricida.com |
Locations


United States, Arizona | |
Investigative Site 4121 | Recruiting |
Mesa, Arizona, United States, 85210 | |
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United States, California | |
Investigative Site 4136 | Recruiting |
Azusa, California, United States, 91702 | |
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Investigative Site 4110 | Withdrawn |
Bakersfield, California, United States, 93309 | |
Investigative Site 4113 | Withdrawn |
Sacramento, California, United States, 95825 | |
United States, Colorado | |
Investigative Site 4119 | Recruiting |
Aurora, Colorado, United States, 80045 | |
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Investigative Site 4148 | Recruiting |
Denver, Colorado, United States, 80230 | |
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United States, Connecticut | |
Investigative Site 4120 | Withdrawn |
Stamford, Connecticut, United States, 06902 | |
United States, Florida | |
Investigative Site 4146 | Recruiting |
Bradenton, Florida, United States, 34209 | |
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Investigative Site 4102 | Recruiting |
Coral Springs, Florida, United States, 33071 | |
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Investigative Site 4153 | Recruiting |
Fort Lauderdale, Florida, United States, 33308 | |
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Investigative Site 4122 | Recruiting |
Hollywood, Florida, United States, 33021 | |
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Investigative Site 4123 | Recruiting |
Hollywood, Florida, United States, 33024 | |
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Investigative Site 4133 | Withdrawn |
Lauderdale Lakes, Florida, United States, 33313 | |
Investigative Site 4144 | Recruiting |
Miami Gardens, Florida, United States, 33169 | |
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Investigative Site 4130 | Recruiting |
Miami Lakes, Florida, United States, 33014 | |
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Investigative Site 4104 | Recruiting |
Miami, Florida, United States, 33015 | |
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Investigative Site 4138 | Withdrawn |
Miami, Florida, United States, 33145 | |
Investigative Site 4116 | Recruiting |
Port Charlotte, Florida, United States, 33952 | |
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Investigative Site 4152 | Recruiting |
Tampa, Florida, United States, 33637 | |
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United States, Georgia | |
Investigative Site 4127 | Recruiting |
Augusta, Georgia, United States, 30904 | |
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United States, Maryland | |
Investigative Site 4141 | Recruiting |
Greenbelt, Maryland, United States, 20770 | |
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United States, Missouri | |
Investigative Site 4155 | Recruiting |
Kansas City, Missouri, United States, 64111 | |
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United States, Nevada | |
Investigative Site 4140 | Withdrawn |
Las Vegas, Nevada, United States, 89102 | |
United States, North Carolina | |
Investigative Site 4125 | Withdrawn |
Charlotte, North Carolina, United States, 28207 | |
Investigative Site 4108 | Recruiting |
Greenville, North Carolina, United States, 27834 | |
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Investigative Site 4139 | Withdrawn |
Greenville, North Carolina, United States, 27834 | |
Investigative Site 4106 | Recruiting |
Kinston, North Carolina, United States, 28504 | |
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Investigative Site 4107 | Recruiting |
New Bern, North Carolina, United States, 28562 | |
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United States, Ohio | |
Investigative Site 4135 | Withdrawn |
Cincinnati, Ohio, United States, 45206 | |
United States, Pennsylvania | |
Investigative Site 4124 | Recruiting |
Bethlehem, Pennsylvania, United States, 18017 | |
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United States, South Carolina | |
Investigative Site 4128 | Recruiting |
Greer, South Carolina, United States, 29651 | |
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Investigative Site 4143 | Recruiting |
Orangeburg, South Carolina, United States, 29118 | |
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United States, Tennessee | |
Investigative Site 4112 | Withdrawn |
Chattanooga, Tennessee, United States, 37408 | |
Investigative Site 4137 | Withdrawn |
Knoxville, Tennessee, United States, 37923 | |
Investigative Site 4132 | Recruiting |
Nashville, Tennessee, United States, 37205 | |
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United States, Texas | |
Investigative Site 4142 | Withdrawn |
Katy, Texas, United States, 77494 | |
Investigative Site 4134 | Withdrawn |
San Antonio, Texas, United States, 78207 | |
Investigative Site 4131 | Withdrawn |
Sugar Land, Texas, United States, 77478 | |
United States, Utah | |
Investigative Site 4111 | Recruiting |
Saint George, Utah, United States, 84790 | |
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United States, Vermont | |
Investigative Site 4105 | Withdrawn |
Burlington, Vermont, United States, 05401 | |
United States, Washington | |
Investigative Site 4101 | Withdrawn |
Tacoma, Washington, United States, 98405 | |
Albania | |
Investigative Site 1102 | Recruiting |
Fier, Albania, 9300 | |
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Investigative Site 1103 | Recruiting |
Shkodër, Albania, 4001 | |
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Investigative Site 1101 | Recruiting |
Tirana, Albania, 1023 | |
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Argentina | |
Investigative Site 4407 | Recruiting |
Buenos Aires, Argentina, B2800DGH | |
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Investigative Site 4402 | Recruiting |
Buenos Aires, Argentina, B6000GMA | |
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Investigative Site 4404 | Recruiting |
Buenos Aires, Argentina, B7600FZN | |
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Investigative Site 4411 | Recruiting |
Buenos Aires, Argentina, C1012AAR | |
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Investigative Site 4401 | Recruiting |
Buenos Aires, Argentina, C1429BWN | |
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Investigative Site 4410 | Recruiting |
Corrientes, Argentina, W3400AMZ | |
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Investigative Site 4414 | Recruiting |
Córdoba, Argentina, X5000AAW | |
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Investigative Site 4408 | Recruiting |
Córdoba, Argentina, X5002AOQ | |
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Investigative Site 4405 | Recruiting |
Mar Del Plata, Argentina, B7600FYK | |
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Investigative Site 4409 | Recruiting |
San Luis, Argentina, D5700CGR | |
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Investigative Site 4403 | Recruiting |
Santa Fe, Argentina, S3000EPV | |
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Armenia | |
Investigative Site 2803 | Recruiting |
Yerevan, Armenia, 0014 | |
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Investigative Site 2806 | Recruiting |
Yerevan, Armenia, 0014 | |
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Investigative Site 2809 | Recruiting |
Yerevan, Armenia, 0015 | |
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Investigative Site 2802 | Recruiting |
Yerevan, Armenia, 0025 | |
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Investigative site 2801 | Recruiting |
Yerevan, Armenia, 0052 | |
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Investigative Site 2805 | Recruiting |
Yerevan, Armenia, 0075 | |
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Investigative Site 2807 | Recruiting |
Yerevan, Armenia, 0078 | |
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Investigative Site 2804 | Recruiting |
Yerevan, Armenia, 0087 | |
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Australia | |
Investigative Site 5110 | Recruiting |
Benowa, Australia, 4217 | |
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Investigative Site 5105 | Recruiting |
Clayton, Australia, 3168 | |
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Investigative Site 5107 | Recruiting |
Fitzroy, Australia, 3065 | |
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Investigative Site 5101 | Recruiting |
Gosford, Australia, 2250 | |
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Investigative Site 5106 | Recruiting |
New Lambton Heights, Australia, 2305 | |
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Investigative Site 5102 | Recruiting |
Parkville, Australia, 3052 | |
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Belarus | |
Investigative Site 1506 | Recruiting |
Gomel, Belarus, 246029 | |
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Investigative Site 1502 | Recruiting |
Grodno, Belarus, 230017 | |
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Investigative Site 1501 | Recruiting |
Minsk, Belarus, 220045 | |
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Investigative Site 1503 | Recruiting |
Minsk, Belarus, 223041 | |
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Investigative Site 1505 | Recruiting |
Vitebsk, Belarus, 210037 | |
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Belgium | |
Investigative Site 3105 | Recruiting |
Antwerpen, Belgium, 2820 | |
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Investigative Site 3104 | Withdrawn |
Brussels, Belgium, 1070 | |
Investigative Site 3102 | Withdrawn |
Gent, Belgium, 9000 | |
Investigative Site 3108 | Recruiting |
Liège, Belgium, 3108 | |
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Investigative Site 3103 | Recruiting |
Liège, Belgium, 4000 | |
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Investigative Site 3107 | Withdrawn |
Roeselare, Belgium, 8800 | |
Investigative Site 3109 | Recruiting |
Tournai, Belgium, 7500 | |
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Brazil | |
Investigative Site 4513 | Recruiting |
Brasília, Brazil, 71625-175 | |
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Investigative Site 4518 | Recruiting |
Caxias Do Sul, Brazil, 95010-005 | |
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Investigative Site 4516 | Recruiting |
Curitiba, Brazil, 80060-150 | |
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Investigative Site 4504 | Recruiting |
Curitiba, Brazil, 80440-020 | |
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Investigative Site 4514 | Recruiting |
Fortaleza, Brazil, 60430-270 | |
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Investigative Site 4507 | Recruiting |
Juiz De Fora, Brazil, 36036-330 | |
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Investigative Site 4510 | Recruiting |
Porto Alegre, Brazil, 90035-074 | |
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Investigative Site 4503 | Withdrawn |
Porto Alegre, Brazil, 90610-000 | |
Investigative Site 4501 | Recruiting |
São Paulo, Brazil, 01228-200 | |
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Investigative Site 4517 | Recruiting |
São Paulo, Brazil, 01323-903 | |
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Investigative Site 4512 | Recruiting |
São Paulo, Brazil, 08270-070 | |
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Investigative Site 4508 | Recruiting |
São Paulo, Brazil, 09090-790 | |
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Investigative Site 4509 | Recruiting |
São Paulo, Brazil, 09715-090 | |
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Investigative Site 4506 | Recruiting |
São Paulo, Brazil, 15090-000 | |
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Investigative Site 4519 | Recruiting |
São Paulo, Brazil, 18618-686 | |
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Investigative Site 4511 | Recruiting |
Votuporanga, Brazil, 15500-003 | |
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Bulgaria | |
Investigative Site 1211 | Recruiting |
Kozloduy, Bulgaria, 3320 | |
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Investigative Site 1213 | Recruiting |
Montana, Bulgaria, 3400 | |
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Investigative Site 1210 | Recruiting |
Pleven, Bulgaria, 5800 | |
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Investigative Site 1205 | Recruiting |
Ruse, Bulgaria, 7000 | |
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Investigative Site 1212 | Recruiting |
Ruse, Bulgaria, 7000 | |
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Investigative Site 1206 | Recruiting |
Sevlievo, Bulgaria, 5400 | |
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Investigative Site 1204 | Recruiting |
Sliven, Bulgaria, 8800 | |
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Investigative Site 1201 | Recruiting |
Sofia, Bulgaria, 1612 | |
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Investigative Site 1207 | Withdrawn |
Sofia, Bulgaria, 1612 | |
Investigative Site 1202 | Withdrawn |
Stara Zagora, Bulgaria, 6100 | |
Investigative Site 1208 | Recruiting |
Veliko Tarnovo, Bulgaria, 5000 | |
Contact: Clinical Operations | |
Investigative Site 1203 | Recruiting |
Yambol, Bulgaria, 8600 | |
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Canada, Ontario | |
Investigative Site 4207 | Withdrawn |
Concord, Ontario, Canada, L4K 4M2 | |
Investigative Site 4202 | Recruiting |
Kitchener, Ontario, Canada, N2H 5Z8 | |
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Canada | |
Investigative Site 4203 | Recruiting |
Brampton, Canada, L6S 0C9 | |
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Investigative Site 4201 | Recruiting |
London, Canada, N6A 5A5 | |
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Investigative Site 4205 | Withdrawn |
Oakville, Canada, L6K 3V3 | |
Investigative Site 4204 | Recruiting |
Québec, Canada, G1R 2J6 | |
Contact: Clinical Operations | |
Investigative Site 4208 | Recruiting |
Winnipeg, Canada, R2V 3M3 | |
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Chile | |
Investigative Site 4604 | Recruiting |
Concepción, Chile, 4070038 | |
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Investigative Site 4603 | Recruiting |
La Serena, Chile, 1720421 | |
Contact: Clinical Operations | |
Investigative Site 4601 | Recruiting |
Providencia, Chile, 7500739 | |
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Investigative Site 4605 | Withdrawn |
Santiago, Chile, 7500922 | |
Investigative Site 4602 | Recruiting |
Temuco, Chile, 4781151 | |
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Investigative Site 4606 | Recruiting |
Valdivia, Chile, 5110683 | |
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Colombia | |
Investigative Site 4703 | Recruiting |
Barranquilla, Colombia, 080020 | |
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Investigative Site 4708 | Recruiting |
Barranquilla, Colombia, 080020 | |
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Investigative Site 4701 | Recruiting |
Bogotá, Colombia, 111111 | |
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Investigative Site 4713 | Recruiting |
Bogotá, Colombia, 111411 | |
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Investigative Site 4706 | Recruiting |
Manizales, Colombia, 170003 | |
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Investigative Site 4715 | Recruiting |
Santander, Colombia, 681004 | |
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Czechia | |
Investigative Site 2103 | Withdrawn |
Mariánské Lázně, Czechia, 353 01 | |
Investigative Site 2101 | Recruiting |
Nový Jičín, Czechia, 741 01 | |
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Investigative Site 2102 | Recruiting |
Praha, Czechia, 128 08 | |
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Investigative Site 2105 | Recruiting |
Slaný, Czechia, 274 01 | |
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Investigative Site 2106 | Recruiting |
Sokolov, Czechia, 356 01 | |
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Investigative Site 2107 | Recruiting |
Znojmo, Czechia, 669 03 | |
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France | |
Investigative Site 3201 | Recruiting |
Annonay, France, 07100 | |
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Investigative Site 3209 | Recruiting |
Boulogne-Billancourt, France, 92100 | |
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Investigative Site 3210 | Withdrawn |
Caen, France, 14033 | |
Investigative Site 3205 | Recruiting |
Lille, France, 59000 | |
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Investigative Site 3211 | Withdrawn |
Marseille, France, 13385 | |
Investigative Site 3208 | Recruiting |
Nantes, France, 44093 | |
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Investigative Site 3202 | Withdrawn |
Paris, France, 75020 | |
Investigative Site 3207 | Recruiting |
Saint-Étienne, France, 42055 | |
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Investigative Site 3204 | Withdrawn |
Venissieux, France, 69200 | |
Georgia | |
Investigative Site 2201 | Recruiting |
Batumi, Georgia, 6010 | |
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Investigative Site 2202 | Recruiting |
Kutaisi, Georgia, 4600 | |
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Investigative Site 2208 | Recruiting |
Tbilisi, Georgia, 0102 | |
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Investigative Site 2205 | Recruiting |
Tbilisi, Georgia, 0112 | |
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Investigative Site 2211 | Recruiting |
Tbilisi, Georgia, 0144 | |
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Investigative Site 2204 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2206 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2207 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2209 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2212 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2213 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2214 | Recruiting |
Tbilisi, Georgia, 0159 | |
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Investigative Site 2210 | Recruiting |
Tbilisi, Georgia, 0186 | |
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Hong Kong | |
Investigative Site 6101 | Recruiting |
Hong Kong, Hong Kong | |
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Investigative Site 6102 | Recruiting |
Hong Kong, Hong Kong | |
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Investigative Site 6103 | Recruiting |
Hong Kong, Hong Kong | |
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Investigative Site 6105 | Recruiting |
Hong Kong, Hong Kong | |
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Investigative Site 6104 | Recruiting |
Sha Tin, Hong Kong | |
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Hungary | |
Investigative Site 2311 | Recruiting |
Baja, Hungary, 6500 | |
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Investigative Site 2302 | Withdrawn |
Budapest, Hungary, 1032 | |
Investigative Site 2312 | Recruiting |
Budapest, Hungary, 1097 | |
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Investigative Site 2304 | Recruiting |
Budapest, Hungary, 1115 | |
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Investigative Site 2303 | Withdrawn |
Budapest, Hungary, 1145 | |
Investigative Site 2306 | Recruiting |
Győr, Hungary, 9023 | |
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Investigative Site 2309 | Recruiting |
Kaposvár, Hungary, 7400 | |
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Investigative Site 2310 | Recruiting |
Kistarcsa, Hungary, 2143 | |
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Investigative Site 2316 | Recruiting |
Nagykanizsa, Hungary, 8800 | |
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Investigative Site 2308 | Recruiting |
Pécs, Hungary, 7624 | |
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Investigative Site 2314 | Withdrawn |
Szekszárd, Hungary, 7100 | |
Investigative Site 2301 | Withdrawn |
Szombathely, Hungary, 9700 | |
Israel | |
Investigative Site 3913 | Recruiting |
Afula, Israel, 1384111 | |
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Investigative Site 3902 | Recruiting |
Ashkelon, Israel, 7830604 | |
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Investigative Site 3904 | Recruiting |
Haifa, Israel, 3436212 | |
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Investigative Site 3909 | Recruiting |
H̱olon, Israel, 5822012 | |
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Investigative Site 3905 | Recruiting |
Jerusalem, Israel, 9103102 | |
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Investigative Site 3908 | Withdrawn |
Jerusalem, Israel, 9112001 | |
Investigative Site 3906 | Recruiting |
Kfar Saba, Israel, 4428164 | |
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Investigative Site 3910 | Recruiting |
Nahariya, Israel, 2210001 | |
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Investigative Site 3907 | Recruiting |
Petah tikva, Israel, 4941492 | |
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Investigative Site 3901 | Withdrawn |
Reẖovot, Israel, 7661041 | |
Investigative Site 3914 | Recruiting |
Tel Aviv, Israel, 6423906 | |
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Investigative Site 3912 | Recruiting |
Tel Aviv, Israel, 6937947 | |
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Investigative Site 3911 | Recruiting |
Tel Aviv, Israel, 6971028 | |
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Investigative Site 3903 | Recruiting |
Tiberias, Israel, 1528001 | |
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Investigative Site 3915 | Recruiting |
Zerifin, Israel, 7030000 | |
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Italy | |
Investigative Site 3404 | Recruiting |
Bologna, Italy, 40138 | |
Contact: Clinical Operations | |
Investigative Site 3407 | Recruiting |
Messina, Italy, 98125 | |
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Investigative Site 3410 | Withdrawn |
Milano, Italy, 20157 | |
Investigative Site 3405 | Recruiting |
Milano, Italy, 20162 | |
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Investigative Site 3406 | Recruiting |
Napoli, Italy, 80131 | |
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Investigative Site 3402 | Recruiting |
Pavia, Italy, 27100 | |
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Korea, Republic of | |
Investigative Site 5207 | Recruiting |
Ansan, Korea, Republic of, 15355 | |
Contact: Clinical Operations | |
Investigative Site 5203 | Recruiting |
Anyang, Korea, Republic of, 14068 | |
Contact: Clinical Operations | |
Investigative Site 5206 | Withdrawn |
Bucheon, Korea, Republic of, 14647 | |
Investigative Site 5211 | Recruiting |
Busan, Korea, Republic of, 49201 | |
Contact: Clinical Operations | |
Investigative Site 5218 | Recruiting |
Cheonan, Korea, Republic of, 31151 | |
Contact: Clinical Operations | |
Investigative Site 5204 | Recruiting |
Daejeon, Korea, Republic of, 35015 | |
Contact: Clinical Operations | |
Investigative Site 5217 | Recruiting |
Goyang-si, Korea, Republic of, 10380 | |
Contact: Clinical Operations | |
Investigative Site 5205 | Recruiting |
Goyang, Korea, Republic of, 10444 | |
Contact: Clinical Operations | |
Investigative Site 5215 | Recruiting |
Guri-si, Korea, Republic of, 11923 | |
Contact: Clinical Operations | |
Investigative Site 5210 | Recruiting |
Seongnam-si, Korea, Republic of, 13620 | |
Contact: Clinical Operations | |
Investigative Site 5214 | Recruiting |
Seoul, Korea, Republic of, 02841 | |
Contact: Clinical Operations | |
Investigative Site 5213 | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Contact: Clinical Operations | |
Investigative Site 5209 | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Contact: Clinical Operations | |
Investigative Site 5208 | Recruiting |
Seoul, Korea, Republic of, 05030 | |
Contact: Clinical Operations | |
Investigative Site 5216 | Recruiting |
Seoul, Korea, Republic of, 05278 | |
Contact: Clinical Operations | |
Investigative Site 5202 | Recruiting |
Uijeongbu, Korea, Republic of, 11765 | |
Contact: Clinical Operations | |
Investigative Site 5212 | Recruiting |
Wŏnju, Korea, Republic of, 26426 | |
Contact: Clinical Operations | |
Malaysia | |
Investigative Site 6209 | Recruiting |
Alor Setar, Malaysia, 05460 | |
Contact: Clinical Operations | |
Investigative Site 6208 | Recruiting |
Klang, Malaysia, 41200 | |
Contact: Clinical Operations | |
Investigative Site 6203 | Recruiting |
Kota Bharu, Malaysia, 15586 | |
Contact: Clinical Operations | |
Investigative Site 6207 | Recruiting |
Kota Bharu, Malaysia, 16150 | |
Contact: Clinical Operations | |
Investigative Site 6202 | Recruiting |
Kuala Lumpur, Malaysia, 59100 | |
Contact: Clinical Operations | |
Investigative Site 6204 | Recruiting |
Kuantan, Malaysia, 25100 | |
Contact: Clinical Operations | |
Investigative Site 6205 | Recruiting |
Kulim, Malaysia, 09000 | |
Contact: Clinical Operations | |
Investigative Site 6210 | Recruiting |
Pulau Pinang, Malaysia, 10450 | |
Contact: Clinical Operations | |
Investigative Site 6206 | Recruiting |
Seri Manjung, Malaysia, 32040 | |
Contact: Clinical Operations | |
Investigative Site 6201 | Recruiting |
Sungai Petani, Malaysia, 08000 | |
Contact: Clinical Operations | |
Mexico | |
Investigative Site 4307 | Recruiting |
Cuernavaca, Mexico, 62250 | |
Contact: Clinical Operations | |
Investigative Site 4314 | Recruiting |
Culiacán, Mexico, 80230 | |
Contact: Clinical Operations | |
Investigative Site 4306 | Recruiting |
Delegación Tlalpan, Mexico, 14080 | |
Contact: Clinical Operations | |
Investigative Site 4313 | Recruiting |
Guadalajara, Mexico, 44130 | |
Contact: Clinical Operations | |
Investigative Site 4308 | Recruiting |
Guadalajara, Mexico, 44340 | |
Contact: Clinical Operations | |
Investigative Site 4304 | Recruiting |
Guadalajara, Mexico, 44600 | |
Contact: Clinical Operations | |
Investigative Site 4303 | Withdrawn |
Mexico City, Mexico, 06100 | |
Investigative Site 4311 | Recruiting |
Mexico City, Mexico, 06100 | |
Contact: Clinical Operations | |
Investigative Site 4302 | Recruiting |
Mexico City, Mexico, 06700 | |
Contact: Clinical Operations | |
Investigative Site 4315 | Recruiting |
Morelia, Mexico, 58249 | |
Contact: Clinical Operations | |
Investigative Site 4316 | Recruiting |
Mérida, Mexico, 97000 | |
Contact: Clinical Operations | |
Investigative Site 4301 | Recruiting |
Mérida, Mexico, 97130 | |
Contact: Clinical Operations | |
Investigative Site 4310 | Recruiting |
Veracruz, Mexico, 91900 | |
Contact: Clinical Operations | |
Investigative Site 4305 | Recruiting |
Xalapa, Mexico, 91193 | |
Contact: Clinical Operations | |
Investigative Site 4312 | Recruiting |
Zapopan, Mexico, 45030 | |
Contact: Clinical Operations | |
Netherlands | |
Investigative Site 3507 | Recruiting |
Alkmaar, Netherlands, 1815 JD | |
Contact: Clinical Operations | |
Investigative Site 3505 | Recruiting |
Amersfoort, Netherlands, 3813 TZ | |
Contact: Clinical Operations | |
Investigative Site 3502 | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Contact: Clinical Operations | |
Investigative Site 3506 | Recruiting |
Apeldoorn, Netherlands, 7334 | |
Contact: Clinical Operations | |
Investigative Site 3504 | Withdrawn |
Breda, Netherlands, 4818 CK | |
Investigative Site 3503 | Recruiting |
Groningen, Netherlands, 2713 | |
Contact: Clinical Operations | |
New Zealand | |
Investigative Site 6302 | Recruiting |
Auckland, New Zealand, 1023 | |
Contact: Clinical Operations | |
Investigative Site 6301 | Recruiting |
Hamilton, New Zealand, 3204 | |
Contact: Clinical Operations | |
Investigative Site 6303 | Withdrawn |
Westown, New Zealand, 4310 | |
North Macedonia | |
Investigative Site 1304 | Recruiting |
Bitola, North Macedonia, 7000 | |
Contact: Clinical Operations | |
Investigative Site 1305 | Recruiting |
Shtip, North Macedonia, 2000 | |
Contact: Clinical Operations | |
Investigative Site 1301 | Recruiting |
Skopje, North Macedonia, 1000 | |
Contact: Clinical Operations | |
Investigative Site 1303 | Recruiting |
Skopje, North Macedonia, 1000 | |
Contact: Clinical Operations | |
Investigative Site 1302 | Recruiting |
Struga, North Macedonia, 6330 | |
Contact: Clinical Operations | |
Poland | |
Investigative Site 2420 | Withdrawn |
Gdańsk, Poland, 80-952 | |
Investigative Site 2408 | Recruiting |
Gdynia, Poland, 81-157 | |
Contact: Clinical Operations | |
Investigative Site 2413 | Recruiting |
Katowice, Poland, 40-027 | |
Contact: Clinical Operations | |
Investigative Site 2423 | Recruiting |
Kielce, Poland, 25-017 | |
Contact: Clinical Operations | |
Investigative Site 2425 | Withdrawn |
Kraków, Poland, 30-510 | |
Investigative Site 2421 | Recruiting |
Kraków, Poland, 31-637 | |
Contact: Clinical Operations | |
Investigative Site 2411 | Recruiting |
Poznań, Poland, 61-655 | |
Contact: Clinical Operations | |
Investigative Site 2422 | Recruiting |
Szczecin, Poland, 70-111 | |
Contact: Clinical Operations | |
Investigative Site 2414 | Recruiting |
Warsaw, Poland, 02-507 | |
Contact: Clinical Operations | |
Investigative Site 2416 | Withdrawn |
Warsaw, Poland, 04-730 | |
Investigative Site 2409 | Withdrawn |
Wrocław, Poland, 50-556 | |
Investigative Site 2406 | Withdrawn |
Wrocław, Poland, 51-162 | |
Investigative Site 2412 | Recruiting |
Zabrze, Poland, 41-800 | |
Contact: Clinical Operations | |
Investigative Site 2424 | Recruiting |
Łódź, Poland, 90-036 | |
Contact: Clinical Operations | |
Investigative Site 2415 | Withdrawn |
Łódź, Poland, 92-213 | |
Investigative Site 2402 | Withdrawn |
Łęczna, Poland, 21-010 | |
Portugal | |
Investigative Site 3604 | Recruiting |
Aveiro, Portugal, 3814-501 | |
Contact: Clinical Operations | |
Investigative Site 3602 | Withdrawn |
Lisboa, Portugal, 1069-166 | |
Investigative Site 3608 | Recruiting |
Lisboa, Portugal, 1649-035 | |
Contact: Clinical Operations | |
Investigative Site 3603 | Recruiting |
Lisboa, Portugal, 2674-514 | |
Contact: Clinical Operations | |
Investigative Site 3607 | Recruiting |
Lisboa, Portugal, 2790-134 | |
Contact: Clinical Operations | |
Investigative Site 3610 | Recruiting |
Porto, Portugal, 4099-001 | |
Contact: Clinical Operations | |
Investigative Site 3609 | Recruiting |
Torres Novas, Portugal, 2350-754 | |
Contact: Clinical Operations | |
Investigative Site 3605 | Recruiting |
Vila Nova De Gaia, Portugal, 4400-129 | |
Contact: Clinical Operations | |
Romania | |
Investigative Site 1401 | Recruiting |
Bucharest, Romania, 010731 | |
Contact: Clinical Operations | |
Investigative Site 1414 | Recruiting |
Bucharest, Romania, 012071 | |
Contact: Clinical Operations | |
Investigative Site 1402 | Recruiting |
Bucharest, Romania, 022328 | |
Contact: Clinical Operations | |
Investigative Site 1406 | Recruiting |
Bucharest, Romania, 022328 | |
Contact: Clinical Operations | |
Investigative Site 1411 | Recruiting |
Bucharest, Romania, 042122 | |
Contact: Clinical Operations | |
Investigative Site 1409 | Recruiting |
Bucharest, Romania, 050098 | |
Contact: Clinical Operations | |
Investigative Site 1413 | Recruiting |
Bucharest, Romania, 440055 | |
Contact: Clinical Operations | |
Investigative Site 1405 | Recruiting |
Craiova, Romania, 200642 | |
Contact: Clinical Operations | |
Investigative Site 1407 | Recruiting |
Deva, Romania, 330025 | |
Contact: Clinical Operations | |
Investigative Site 1412 | Recruiting |
Oradea, Romania, 410469 | |
Contact: Clinical Operations | |
Investigative Site 1408 | Recruiting |
Satu Mare, Romania, 440192 | |
Contact: Clinical Operations | |
Investigative Site 1404 | Recruiting |
Timişoara, Romania, 300723 | |
Contact: Clinical Operations | |
Serbia | |
Investigative Site 2501 | Recruiting |
Belgrade, Serbia, 11000 | |
Contact: Clinical Operations | |
Investigative Site 2507 | Recruiting |
Belgrad, Serbia, 11000 | |
Contact: Clinical Operations | |
Investigative Site 2512 | Recruiting |
Belgrad, Serbia, 11000 | |
Contact: Clinical Operations | |
Investigative Site 2508 | Recruiting |
Kragujevac, Serbia, 34000 | |
Contact: Clinical Operations | |
Investigative Site 2510 | Recruiting |
Krusevac, Serbia, 37000 | |
Contact: Clinical Operations | |
Investigative Site 2505 | Recruiting |
Niš, Serbia, 18000 | |
Contact: Clinical Operations | |
Investigative Site 2509 | Recruiting |
Novi Sad, Serbia, 21000 | |
Contact: Clinical Operations | |
Investigative Site 2514 | Recruiting |
Užice, Serbia, 31000 | |
Contact: Clinical Operations | |
Investigative Site 2503 | Recruiting |
Vršac, Serbia, 26300 | |
Contact: Clinical Operations | |
Investigative Site 2511 | Recruiting |
Zaječar, Serbia, 19000 | |
Contact: Clinical Operations | |
Singapore | |
Investigative Site 6401 | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Clinical Operations | |
Investigative Site 6403 | Recruiting |
Singapore, Singapore, 169856 | |
Contact: Clinical Operations | |
Investigative Site 6404 | Recruiting |
Singapore, Singapore, 529889 | |
Contact: Clinical Operations | |
Slovakia | |
Investigative Site 2602 | Withdrawn |
Bratislava, Slovakia, 82606 | |
Investigative Site 2605 | Withdrawn |
Bratislava, Slovakia, 831 01 | |
Investigative Site 2601 | Withdrawn |
Hlohovec, Slovakia, 920 01 | |
Investigative Site 2604 | Recruiting |
Košice, Slovakia, 04001 | |
Contact: Clinical Operations | |
Investigative Site 2606 | Recruiting |
Košice, Slovakia, 04011 | |
Contact: Clinical Operations | |
Investigative Site 2603 | Recruiting |
Svidník, Slovakia, 08901 | |
Contact: Clinical Operations | |
Spain | |
Investigative Site 3711 | Recruiting |
Almería, Spain, 04003 | |
Contact: Clinical Operations | |
Investigative Site 3705 | Withdrawn |
Barcelona, Spain, 08003 | |
Investigative Site 3716 | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Clinical Operations | |
Investigative Site 3707 | Recruiting |
Barcelona, Spain, 08907 | |
Contact: Clinical Operations | |
Investigative Site 3706 | Recruiting |
Barcelona, Spain, 25198 | |
Contact: Clinical Operations | |
Investigative Site 3701 | Withdrawn |
Bilbao, Spain, 48013 | |
Investigative Site 3717 | Recruiting |
Córdoba, Spain, 14004 | |
Contact: Clinical Operations | |
Investigative Site 3710 | Withdrawn |
Girona, Spain, 17007 | |
Investigative Site 3713 | Recruiting |
La Coruña, Spain, 15405 | |
Contact: Clinical Operations | |
Investigative Site 3704 | Withdrawn |
Lugo, Spain, 27880 | |
Investigative Site 3714 | Recruiting |
Sevilla, Spain, 41009 | |
Contact: Clinical Operations | |
Investigative Site 3712 | Withdrawn |
Valencia, Spain, 46010 | |
Investigative Site 3709 | Recruiting |
Valencia, Spain, 46014 | |
Contact: Clinical Operations | |
Investigative Site 3703 | Recruiting |
Zaragoza, Spain, 50009 | |
Contact: Clinical Operations | |
Taiwan | |
Investigative Site 6512 | Recruiting |
Changhua, Taiwan, 50006 | |
Contact: Clinical Operations | |
Investigative Site 6502 | Recruiting |
Hualien City, Taiwan, 97002 | |
Contact: Clinical Operations | |
Investigative Site 6501 | Recruiting |
Kaohsiung, Taiwan, 81362 | |
Contact: Clinical Operations | |
Investigative Site 6504 | Recruiting |
New Taipei City, Taiwan, 220 | |
Contact: Clinical Operations | |
Investigative Site 6508 | Recruiting |
New Taipei City, Taiwan, 23148 | |
Contact: Clinical Operations | |
Investigative Site 6506 | Recruiting |
Taichung, Taiwan, 40201 | |
Contact: Clinical Operations | |
Investigative Site 6510 | Recruiting |
Taichung, Taiwan, 40447 | |
Contact: Clinical Operations | |
Investigative Site 6505 | Recruiting |
Taichung, Taiwan, 40705 | |
Contact: Clinical Operations | |
Investigative Site 6507 | Recruiting |
Taichung, Taiwan, 433 | |
Contact: Clinical Operations | |
Investigative Site 6503 | Recruiting |
Tainan, Taiwan, 71004 | |
Contact: Clinical Operations | |
Investigative Site 6509 | Recruiting |
Taipei, Taiwan, 10002 | |
Contact: Clinical Operations | |
Investigative Site 6511 | Recruiting |
Taipei, Taiwan, 11031 | |
Contact: Clinical Operations | |
Ukraine | |
Investigative Site 2712 | Recruiting |
Dnipro, Ukraine, 49102 | |
Contact: Clinical Operations | |
Investigative Site 2720 | Recruiting |
Ivano-Frankivs'k, Ukraine, 76008 | |
Contact: Clinical Operations | |
Investigative Site 2714 | Recruiting |
Ivano-Frankivs'k, Ukraine, 76018 | |
Contact: Clinical Operations | |
Investigative Site 2717 | Recruiting |
Kharkiv, Ukraine, 61002 | |
Contact: Clinical Operations | |
Investigative Site 2713 | Recruiting |
Kharkiv, Ukraine, 61039 | |
Contact: Clinical Operations | |
Investigative Site 2704 | Recruiting |
Kharkiv, Ukraine, 61103 | |
Contact: Clinical Operations | |
Investigative Site 2707 | Recruiting |
Kharkiv, Ukraine, 61106 | |
Contact: Clinical Operations | |
Investigative Site 2706 | Recruiting |
Kyiv, Ukraine, 01601 | |
Contact: Clinical Operations | |
Investigative Site 2703 | Recruiting |
Kyiv, Ukraine, 02125 | |
Contact: Clinical Operations | |
Investigative Site 2709 | Recruiting |
Kyiv, Ukraine, 03680 | |
Contact: Clinical Operations | |
Investigative Site 2705 | Recruiting |
Kyiv, Ukraine, 04050 | |
Contact: Clinical Operations | |
Investigative Site 2710 | Recruiting |
Kyiv, Ukraine, 04114 | |
Contact: Clinical Operations | |
Investigative Site 2716 | Recruiting |
Kyiv, Ukraine, 04114 | |
Contact: Clinical Operations | |
Investigative Site 2708 | Recruiting |
Odesa, Ukraine, 65025 | |
Contact: Clinical Operations | |
Investigative Site 2718 | Recruiting |
Ternopil', Ukraine, 46002 | |
Contact: Clinical Operations | |
Investigative Site 2723 | Recruiting |
Zaporizhzhya, Ukraine, 69001 | |
Contact: Clinical Operations | |
Investigative Site 2719 | Recruiting |
Zaporizhzhya, Ukraine, 69600 | |
Contact: Clinical Operations | |
Investigative Site 2715 | Recruiting |
Zhytomyr, Ukraine, 10002 | |
Contact: Clinical Operations | |
United Kingdom | |
Investigative Site 3814 | Recruiting |
Belfast, United Kingdom, BT9 7AB | |
Contact: Clinical Operations | |
Investigative Site 3815 | Recruiting |
Coventry, United Kingdom, CV2 2DX | |
Contact: Clinical Operations | |
Investigative Site 3816 | Withdrawn |
Leeds, United Kingdom, LS9 7TF | |
Investigative Site 3802 | Recruiting |
Leicester, United Kingdom, LE5 4PW | |
Contact: Clinical Operations | |
Investigative Site 3813 | Recruiting |
London, United Kingdom, NW3 2QG | |
Contact: Clinical Operations | |
Investigative Site 3812 | Recruiting |
London, United Kingdom, SW17 0QT | |
Contact: Clinical Operations | |
Investigative Site 3805 | Recruiting |
Manchester, United Kingdom, M13 9WL | |
Contact: Clinical Operations | |
Investigative Site 3804 | Recruiting |
Nottingham, United Kingdom, NG5 1PB | |
Contact: Clinical Operations | |
Investigative Site 3810 | Recruiting |
Plymouth, United Kingdom, PL6 8DH | |
Contact: Clinical Operations | |
Investigative Site 3811 | Recruiting |
Preston, United Kingdom, PR2 9HT | |
Contact: Clinical Operations | |
Investigative Site 3801 | Recruiting |
Swansea, United Kingdom, SA6 6NL | |
Contact: Clinical Operations | |
Investigative Site 3809 | Withdrawn |
York, United Kingdom, YO31 8HE |
Sponsors and Collaborators
Tricida, Inc.
Responsible Party: | Tricida, Inc. |
ClinicalTrials.gov Identifier: | NCT03710291 |
Other Study ID Numbers: |
TRCA-303 2018-001303-36 ( EudraCT Number ) |
First Posted: | October 18, 2018 Key Record Dates |
Last Update Posted: | December 9, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tricida, Inc.:
serum bicarbonate renal outcomes TRC101 eGFR veverimer |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Acidosis Urologic Diseases |
Renal Insufficiency Acid-Base Imbalance Metabolic Diseases |