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Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI

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ClinicalTrials.gov Identifier: NCT03602261
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Ireland Global Holdings Ltd.

Brief Summary:
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Due to Renal Causes Chronic Kidney Diseases Vitamin D Deficiency Stage 5 Chronic Kidney Disease Drug: Calcifediol Oral Capsule Drug: Placebo oral capsule Phase 2

Detailed Description:
A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects with Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Two-Cohort Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of CTAP101 (Calcifediol) Extended-Release Capsules to Treat Secondary Hyperparathyroidism in Subjects With Vitamin D Insufficiency and Chronic Kidney Disease Requiring Regular Hemodialysis.
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol

Arm Intervention/treatment
Active Comparator: CTAP101 Capsules 300mcg/weekly
CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 300mcg/weekly for 26 weeks
Drug: Calcifediol Oral Capsule
Capsule, weekly
Other Name: CTAP101

Active Comparator: CTAP101 Capsules 600mcg/weekly
CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 600mcg/weekly for 26 weeks
Drug: Calcifediol Oral Capsule
Capsule, weekly
Other Name: CTAP101

Active Comparator: CTAP101 Capsules 900mcg/weekly
CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks
Drug: Calcifediol Oral Capsule
Capsule, weekly
Other Name: CTAP101

Placebo Comparator: Placebo Capsules weekly
Placebo Oral Capsules/weekly for 26 weeks
Drug: Placebo oral capsule
Capsule, weekly




Primary Outcome Measures :
  1. Change of mean plasma intact parathyroid hormone (iPTH) [ Time Frame: 26 weeks ]
    Change of at least 30% from pre-treatment baseline

  2. Severity of Treatment-Emergent Adverse Events as assessed by CTCAE version 5.0 [ Time Frame: 32 weeks ]
    Detailed information collected for each TEAE will include: AE number, a description of the event, start date, end date or ongoing as of date, outcome, therapy for event

  3. Maximum Plasma Concentration [Cmax] [ Time Frame: 74 weeks ]
    Maximum serum concentration of Calcifediol

  4. Increase mean serum total 25-hydroxyvitamin D [ Time Frame: 26 weeks ]
    Increase to ≥30 ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled into the two cohorts of this study:

  1. Be at least 18 years of age.
  2. Be diagnosed with CKD requiring in-center HD tiw for the preceding 6 months, as confirmed by medical history.
  3. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation, including:

    1. Serum albumin ≤ 3.0 g/dL; and,
    2. Serum transaminase (alanine transaminase [ALT], glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or glutamic oxaloacetic transaminase [SGOT]) > 2.5 times the upper limit of normal at screening.
  4. Be receiving calcimimetic therapy (either etelcalcetide or cinacalcet) and/or calcitriol or other 1α-hydroxylated vitamin D analog (paricalcitol or doxercalciferol) for at least 1 month at the time of screening for enrollment. At least 50% of enrolled subjects will have been receiving calcimimetic therapy.
  5. Exhibit during the initial screening visit:

    1. Plasma iPTH ≥150 pg/mL and <600 pg/mL if receiving etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analog (paricalcitol or doxercalciferol); or
    2. Plasma iPTH ≥300 pg/mL and <900 pg/mL if not receiving etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analog; and,
    3. Serum total 25-hydroxyvitamin D <30 ng/mL if not receiving vitamin D supplementation.
  6. When otherwise confirmed eligible at Visit 1, must forgo any further treatment with etelcalcetide and cinacalcet for the duration of the study and undergo an 8-week washout period.
  7. When otherwise confirmed eligible at Visit 1, must forgo any further treatment with calcitriol or other 1α-hydroxylated vitamin D analogs or vitamin D supplements for the duration of the study and undergo an 8-week washout period.
  8. Exhibit after the 8-week washout period (if required due to prior use of etelcalcetide, cinacalcet, calcitriol or other 1α-hydroxylated vitamin D analogs, or vitamin D supplementation):

    Cohort 1:

    1. Plasma iPTH increased by at least 50%; and,
    2. Plasma iPTH ≥300 pg/mL and <1,200 pg/mL; or,

    Cohort 2:

    a. Plasma iPTH ≥300 pg/mL and <1,200 pg/mL (approximately half of the subjects will be enrolled in each of these two iPTH strata: ≥300 to <600 and ≥600 to <1,200 pg/mL); and

    Cohorts 1 and 2:

    1. Corrected serum calcium <9.8 mg/dL;
    2. Serum total 25-hydroxyvitamin D <30 ng/mL; and,
    3. Serum phosphorus <6.5 mg/dL.
  9. When otherwise confirmed eligible at Visit 1, if taking more than 1,000 mg per day of elemental calcium, reduce calcium use (to ≤1,000 mg per day) and/or use non-calcium based phosphate binder therapies (as needed) for the duration of the study.
  10. When otherwise confirmed eligible at Visit 1, if taking bone metabolism therapies that may interfere with study endpoints, must discontinue use of these agents for the duration of the study.
  11. Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study.
  12. Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test at the first screening visit and at other scheduled times.
  13. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.
  14. Be able to read, understand and sign the subject Informed Consent Form (ICF) or have a legal representative sign the ICF.

4.3 Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

  1. Scheduled kidney transplant or parathyroidectomy.
  2. History (prior 2 months) of corrected serum calcium ≥9.8 mg/dL or serum phosphorus

    ≥6.5 mg/dL if not receiving calcitriol or other 1α-hydroxylated vitamin D analog.

  3. Receipt of bisphosphonate therapy or other bone modifying treatment (eg, denosumab) within 6 months prior to enrollment.
  4. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease, intestinal malabsorption disorder, hepatitis or cardiovascular event that in the opinion of the investigator may worsen or reduce life expectancy, and/or interfere with participation in the study.
  5. History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely.
  6. Known or suspected hypersensitivity to any of the constituents of the study drugs.
  7. Currently participating in, or has participated in, an interventional/investigational study within 30 days prior to study 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): NCT03602261


Contacts
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Contact: Luis R Paredes 13055754167 lparedes@opko.com
Contact: Evelyn Cheng 13055754129 echeng@opko.com

Locations
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United States, Arizona
AKDHC Medical Research Services Recruiting
Peoria, Arizona, United States, 85381
Contact: Marcie Sears    623-974-1763    msears@akdhc.com   
Principal Investigator: Suzan Buxton, MD         
AKDHC Medical Research Services Recruiting
Phoenix, Arizona, United States, 85027
Contact: Ciria Luevano    623-780-1371 ext 3720    cluevano@akdhc.com   
Principal Investigator: Sungchun Lee, MD         
AKDHC Medical Research Services Recruiting
Phoenix, Arizona, United States, 85035
Contact: Erica Diaz    619-461-3894    ediaz@akdhc.com   
Principal Investigator: Nilda R. Neyra, MD         
AKDHC Medical Research Services Recruiting
Phoenix, Arizona, United States, 85258
Contact: Ciria Luevano    623-780-1371 ext 3720    cluevano@akdhc.com   
Principal Investigator: Romanita Nica, MD         
United States, California
WCCT Global, Inc. Active, not recruiting
Cypress, California, United States, 90630
Hacienda Dialysis Center Terminated
Hacienda Heights, California, United States, 91745
California Institute of Renal Research CKD/Dialysis & Transplant Division Recruiting
La Mesa, California, United States, 91942
Contact: Lorena Hernandez    619-461-3894      
Principal Investigator: George Fadda, MD         
Long Beach Quest Dialysis Center Terminated
Long Beach, California, United States, 90807
Ontario Dialysis Center Recruiting
Ontario, California, United States, 91762
Contact: Bonnie Garcia    626-587-9624      
Principal Investigator: Abid Khan, MD         
North America Research Institute, Inc. Recruiting
San Dimas, California, United States, 91773
Contact: Jenny Nguyen    800-797-1695      
Principal Investigator: Aamir Jamal, MD         
Laurel Canyon Dialysis, LLC Recruiting
Sun Valley, California, United States, 91352
Contact: Virginia Leonte    661-753-3654      
Principal Investigator: Omaran Abdeen, MD         
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Beverly Farmer, RN    303-724-7790    Beverly.Farmer@ucdenver.edu   
Principal Investigator: Michel Chonchol, MD         
United States, Illinois
Research by Design, LLC Recruiting
Chicago, Illinois, United States, 60643
Contact: Bridget Ross    708-952-3040      
Principal Investigator: Paul Crawford, MD         
Northshore University Health Recruiting
Evanston, Illinois, United States, 60201
Contact: Robert Stanton    224-364-7242      
Principal Investigator: Stuart Sprague, MD         
United States, Massachusetts
Renal and Transplant Associates of New England Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Joy Whitbeck    413-731-1008 ext 700    jwhitbeck@rtane.org   
Principal Investigator: Michael Germain, MD         
United States, Mississippi
Southwest MS Nephrology Recruiting
McComb, Mississippi, United States, 39601
Contact: Melanie Haydel, RN    601-684-6380    mhaydel@southwmn.com   
Principal Investigator: Paul Dykes, MD         
United States, Texas
Southwest Houston Research LTD Recruiting
Houston, Texas, United States, 77099
Contact: Darlene Chidolue    281-598-2210 ext 107    darlene.chidolue@swhresearch.com   
Principal Investigator: Marializa Bernardo, MD         
Kidney & Hypertension Specialists Recruiting
San Antonio, Texas, United States, 78207
Contact: Reynaldo Sosa    210-277-1418      
Principal Investigator: Srinath Tamirisa, MD         
Sponsors and Collaborators
OPKO Ireland Global Holdings Ltd.

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Responsible Party: OPKO Ireland Global Holdings Ltd.
ClinicalTrials.gov Identifier: NCT03602261     History of Changes
Other Study ID Numbers: CTAP101-CL-2010
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vitamin D Deficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents