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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
1 mcg daily, adjusted to achieve 40-60% PTH suppression
0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
Northwestern University
Chicago, Illinois, United States
Northshore University Health System
Evanston, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Confirmed Hypercalcemia
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Time frame: 24 week treatment period
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