Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

September 30, 2014

Conditions
Chronic Kidney DiseaseHyperparathyroidism, SecondaryVitamin D Deficiency
Interventions
DRUG

CTAP101 30 μg capsules

CTAP101 30 μg capsule taken daily at bedtime

OTHER

Sugar pill to CTAP101 30 μg capsules

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

Trial Locations (1)

60015

OPKO Renal, Bannockburn

All Listed Sponsors
lead

OPKO IP Holdings II, Inc.

INDUSTRY

NCT01704079 - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency | Biotech Hunter | Biotech Hunter