Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

Status:	Archived
Conditions:	Renal Impairment / Chronic Kidney Disease, Endocrine
Therapuetic Areas:	Endocrinology, Nephrology / Urology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	February 2009
End Date:	June 2010

A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism

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.

We found this trial at

sites

Washington University

1 Brookings Drive
St. Louis, Missouri 63110

(314) 935-5000