CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Calcifediol Oral Capsule +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03588884
NCT03588884Phase 4Completed
CompareCT.gov

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

OPKO Health, Inc.·interventional·Posted Jul 17, 2018·Updated Dec 9, 2022

In Brief

A Phase 4 clinical trial evaluating Calcifediol Oral Capsule, Calcifediol Oral Product, and 2 other interventions for Secondary Hyperparathyroidism Due to Renal Causes and 3 related conditions. Completed, enrolled 69 participants across 3 sites.

Detailed Summary

An Open-Label, Repeated-Dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Oral CTAP101 Capsules, Immediate- Release (IR) Calcifediol, High-Dose Cholecalciferol, and Paricalcitol Plus Low-Dose Cholecalciferol in Patients with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism Due to Renal Causes, Vitamin D Insufficiency, CKD Stage 3, CKD Stage 4
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 17, 2018
Enrollment StartJun 8, 2018
Primary CompletionApr 24, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.0 years ago

Interventions

Calcifediol Oral Capsuledrug

Capsule, daily

Calcifediol Oral Productdrug

Capsule, once a month

Cholecalciferoldrug

Capsule, once a month

Paricalcitol Oral Capsuledrug

Capsule, daily