Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Public ClinicalTrials.gov record NCT03602261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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.
Study identification
- NCT ID
- NCT03602261
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- OPKO Health, Inc.
- Industry
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Interventions
- Calcifediol Oral Capsule Drug
- Placebo oral capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2018
- Primary completion
- Feb 23, 2021
- Completion
- Feb 23, 2021
- Last update posted
- Apr 2, 2026
2018 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 7
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AKDHC Medical Research Services | Peoria | Arizona | 85381 | — |
| AKDHC Medical Research Services | Phoenix | Arizona | 85027 | — |
| AKDHC Medical Research Services | Phoenix | Arizona | 85035 | — |
| AKDHC Medical Research Services | Phoenix | Arizona | 85258 | — |
| WCCT Global, Inc. | Cypress | California | 90630 | — |
| Hacienda Dialysis Center | Hacienda Heights | California | 91745 | — |
| California Institute of Renal Research CKD/Dialysis & Transplant Division | La Mesa | California | 91942 | — |
| Long Beach Quest Dialysis Center | Long Beach | California | 90807 | — |
| Ontario Dialysis Center | Ontario | California | 91762 | — |
| North America Research Institute, Inc. | San Dimas | California | 91773 | — |
| Laurel Canyon Dialysis, LLC | Sun Valley | California | 91352 | — |
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Research by Design, LLC | Chicago | Illinois | 60643 | — |
| Northshore University Health | Evanston | Illinois | 60201 | — |
| Renal and Transplant Associates of New England | Springfield | Massachusetts | 01107 | — |
| Southwest MS Nephrology | McComb | Mississippi | 39601 | — |
| Southwest Houston Research LTD | Houston | Texas | 77099 | — |
| Kidney & Hypertension Specialists | San Antonio | Texas | 78207 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03602261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03602261 live on ClinicalTrials.gov.