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Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03602261

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 7:18 AM EDT

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

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

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 9, 2018 (Actual)
Primary completion
Feb 24, 2021 (Actual)
Completion
Feb 24, 2021 (Actual)
Last update posted
Apr 3, 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 3, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03602261 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →