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Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects

Chronic Kidney Disease Clinical Trial

Official title:
A Randomized, Open-Label, Single-Dose Pilot Study of Oral and i.v. CTAP101 Evaluating PK and Safety in Stage 3 and 4 CKD Subjects With Vitamin D Insufficiency and SHPT

Clinical Trial Summary

This study will investigate how the levels of a single 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 Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00888069
Study type Interventional
Source OPKO Health, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 2009
Completion date December 2009
View Details
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