CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
Cohort 1 CTAP101 Capsules- 60µg +4 moredrug
Likely dose
Cohort 1 CTAP101 Capsules- 60µgfrom 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/NCT01219855
NCT01219855Phase 3Completed
CompareCT.gov

A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism

OPKO Health, Inc.·interventional·Posted Oct 13, 2010·Updated Aug 25, 2016

In Brief

A Phase 3 clinical trial evaluating Cohort 1 CTAP101 Capsules- 60µg, Cohort 1 CTAP101 Capsules - 90µg, and 3 other interventions for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 13, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago

Interventions

Cohort 1 CTAP101 Capsules- 60µgdrug

60µg of CTAP101 capsules given once daily for 42 days.

Cohort 1 CTAP101 Capsules - 90µgdrug

90µg of CTAP101 capsules given once daily for 42 days.

Cohort 1 Matching Sugar Capsuledrug

Placebo capsules given once daily for 42 days.

Cohort 2 CTAP101 Capsules - 30µgdrug

30µg of CTAP101 capsules given once daily for 42 days.

Cohort 2 Matching Sugar Capsuledrug

Placebo capsules given once daily for 42 days.