NCT02282813View on ClinicalTrials.gov

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

PHASE3CompletedINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Chronic Kidney DiseaseHyperparathyroidism, SecondaryVitamin D Deficiency
Interventions
DRUG

CTAP101 Capsules

At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily

DRUG

Calcitriol

At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily

DRUG

Doxercalciferol

At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily

DRUG

Paricalcitol

At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

All Listed Sponsors
lead

OPKO Health, Inc.

INDUSTRY

NCT02282813 - Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 | Biotech Hunter | Biotech Hunter