Conditions: Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency
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: 78
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Cohort 1 CTAP101 Capsules- 60µg intervention 2: Cohort 1 CTAP101 Capsules - 90µg intervention 3: Cohort 1 Matching Sugar Capsule intervention 4: Cohort 2 CTAP101 Capsules - 30µg intervention 5: Cohort 2 Matching Sugar Capsule
Intervention descriptions: intervention 1: 60µg of CTAP101 capsules given once daily for 42 days. intervention 2: 90µg of CTAP101 capsules given once daily for 42 days. intervention 3: Placebo capsules given once daily for 42 days. intervention 4: 30µg of CTAP101 capsules given once daily for 42 days. intervention 5: Placebo capsules given once daily for 42 days.

Protocol document: