Trial record 2 of 2 for:
TRCA-301
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03317444 |
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Recruitment Status :
Completed
First Posted : October 23, 2017
Last Update Posted : March 26, 2019
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Sponsor:
Tricida, Inc.
Information provided by (Responsible Party):
Tricida, Inc.
- Study Details
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Brief Summary:
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Acidosis | Drug: TRC101 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 217 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis |
| Actual Study Start Date : | September 26, 2017 |
| Actual Primary Completion Date : | May 4, 2018 |
| Actual Study Completion Date : | May 15, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Experimental: TRC101
Administered once daily (QD) for 12 weeks
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Drug: TRC101
Oral suspension
Other Name: Veverimer |
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Placebo Comparator: Placebo
Administered once daily (QD) for 12 weeks
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Drug: Placebo
Oral suspension |
Primary Outcome Measures :
- Change from baseline in blood bicarbonate. [ Time Frame: Week 12 ]Comparison of TRC101 and placebo with regard to the proportions of subjects with change from baseline in blood bicarbonate ≥ 4 mEq/L or with blood bicarbonate in the normal range (22 to 29 mEq/L).
Other Outcome Measures:
- Adverse events, serious adverse events, withdrawal of treatment due to an adverse event. [ Time Frame: Up to Week 14 ]Number and percentage of subjects with treatment-emergent adverse events (TEAEs), number and percentage of subjects experiencing TEAEs by severity, causality, seriousness, and action taken with regard to study drug by treatment group. TEAEs leading to discontinuation of study treatment will be summarized by treatment group.
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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
Key Inclusion Criteria:
- Blood bicarbonate level of 12 to 20 mEq/L.
- Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
- Stable kidney function defined as <=20% variability in eGFR during screening period.
Key Exclusion Criteria:
- Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
- Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
- Heart or kidney transplant.
- Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
- Change in doses to alkali therapy in the 4 weeks prior to screening.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at screening.
- Planned initiation of renal replacement therapy within 12 weeks following randomization.
- Use of polymeric binder drugs within 14 days prior to screening.
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): NCT03317444
Locations
Show 44 study locations
Sponsors and Collaborators
Tricida, Inc.
Investigators
| Study Director: | Yuri Stasiv, PhD | Tricida, Inc. |
Publications of Results:
| Responsible Party: | Tricida, Inc. |
| ClinicalTrials.gov Identifier: | NCT03317444 |
| Other Study ID Numbers: |
TRCA-301 2016-003825-41 ( EudraCT Number ) |
| First Posted: | October 23, 2017 Key Record Dates |
| Last Update Posted: | March 26, 2019 |
| Last Verified: | March 2019 |
| 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.:
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blood bicarbonate, kidney disease |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Acidosis Urologic Diseases |
Renal Insufficiency Acid-Base Imbalance Metabolic Diseases |