Conditions: Chronic Kidney Disease Hyperparathyroidism, Secondary Vitamin D Deficiency
Keywords: Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Hyperparathyroidism, Secondary Vitamin D Hyperparathyroidism Kidney Diseases Kidney Failure Renal Insufficiency, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 298
Healthy volunteers: no

Brief summary:
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

Detailed description:
Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Arms:
arm 1: CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks arm 2: CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks arm 3: CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks arm 4: CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

Interventions: intervention 1: CTAP101 Capsules intervention 2: Calcitriol intervention 3: Doxercalciferol intervention 4: Paricalcitol
Intervention descriptions: intervention 1: At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily intervention 2: At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily intervention 3: At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily intervention 4: At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Protocol document: