NCT01219855

Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Kidney Disease
• Secondary Hyperparathyroidism
• Vitamin D Insufficiency

Interventions

Type	Name	Description
DRUG	Cohort 1 CTAP101 Capsules- 60µg	60µg of CTAP101 capsules given once daily for 42 days.
DRUG	Cohort 1 CTAP101 Capsules - 90µg	90µg of CTAP101 capsules given once daily for 42 days.
DRUG	Cohort 1 Matching Sugar Capsule	Placebo capsules given once daily for 42 days.
DRUG	Cohort 2 CTAP101 Capsules - 30µg	30µg of CTAP101 capsules given once daily for 42 days.
DRUG	Cohort 2 Matching Sugar Capsule	Placebo capsules given once daily for 42 days.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-10-13
• Last updated: 2016-08-25
• Results posted: 2016-08-25

Locations

1 site across 1 country: United States