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

NCT03602261 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-04-03

Study results available
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Summary

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

Conditions

  • Secondary Hyperparathyroidism Due to Renal Causes
  • Chronic Kidney Diseases
  • Vitamin D Deficiency
  • Stage 5 Chronic Kidney Disease

Interventions

DRUG

Calcifediol Oral Capsule

Capsule, weekly

DRUG

Placebo oral capsule

Capsule, weekly

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2021-02-24
Completion
2021-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602261 on ClinicalTrials.gov