Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
- Conditions
- Kidney Disease
- Registration Number
- NCT00091975
- Lead Sponsor
- Abbott
- Brief Summary
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
St. Louis University
🇺🇸St. Louis, Missouri, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Outcomes Research International, Inc.
🇺🇸Hudson, Florida, United States
Associates in Nephrology
🇺🇸Fort Meyers, Florida, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Washington University Medical Center
🇺🇸St. Louis, Missouri, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Nephrology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
Northwestern Renal Clinic, INC.
🇺🇸Portland, Oregon, United States
University of Texas Health Center at San Antonio
🇺🇸San Antonio, Texas, United States
Nea Research
🇺🇸Las Vegas, Nevada, United States
Kidney Associates, PLLC
🇺🇸Houston, Texas, United States