Conditions: Secondary Hyperparathyroidism Chronic Kidney Disease
Keywords: PTH Active Vitamin D hypercalcemia Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 110
Healthy volunteers: no

Brief summary:
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.

Detailed description:
General Design

* Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
* Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
* Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

Arms:
arm 1: titrated to achieve 40-60% PTH suppression arm 2: titrated to achieve 40-60% PTH suppression

Interventions: intervention 1: Paricalcitol intervention 2: Calcitriol
Intervention descriptions: intervention 1: 1 mcg daily, adjusted to achieve 40-60% PTH suppression intervention 2: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Protocol document: