CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 213 enrolled
Drug / intervention
CTAP101 30 μg capsules +1 moredrug
Likely dose
CTAP101 30 μg capsulesfrom 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/NCT01651000
NCT01651000Phase 3Completed
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

OPKO IP Holdings II, Inc.·interventional·Posted Jul 26, 2012·Updated Jan 13, 2025

In Brief

A Phase 3 clinical trial evaluating CTAP101 30 μg capsules and Sugar pill to CTAP101 30 μg capsules for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 213 participants across 1 site.

Detailed Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartSep 1, 2012
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

CTAP101 30 μg capsulesdrug

CTAP101 30 μg capsule taken daily at bedtime.

Sugar pill to CTAP101 30 μg capsulesother

Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.