drugset / Trial / NCT01219855

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

NCT01219855

Phase 2/3 Completed 78 enrolled OPKO Health, Inc.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2010-10
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcifediol Unknown 30 ug
Subject Calcifediol Unknown 60 ug
Subject Calcifediol Unknown 90 ug