Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
- Conditions
- Renal Insufficiency, Chronic
- Registration Number
- NCT00048451
- Lead Sponsor
- Abbott
- Brief Summary
The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
-
Under care of physician at least 2 months (for CKD)
-
Not on active Vitamin D therapy for at least 4 weeks prior
-
If female:
- Not of childbearing potential, OR
- Practicing birth control
- Not breastfeeding
-
If taking phosphate binders, on a stable regimen at least 4 weeks prior
-
For entry into Pretreatment Phase:
- iPTH at least 120 pg/mL
- GFR of 15-60 mL/min and no dialysis expected for at least 6 months
-
For entry into Treatment Phase:
- Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL
- 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
- 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
- History of allergic reaction or sensitivity to similar drugs
- Acute Renal Failure within 12 weeks of study
- Chronic gastrointestinal disease
- Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones
- Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
- Current malignancy, or clinically significant liver disease
- Active granulomatous disease (TB, sarcoidosis, etc.)
- History of drug or alcohol abuse within 6 mos. prior
- Evidence of poor compliance with diet or medication
- Received any investigational drug or participated in any device trial within 30 days prior
- Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
- On glucocorticoids for a period of more than 14 days within the last 6 months
- HIV positive
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 iPTH levels.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Medisphere Medical Research Center
🇺🇸Evansville, Indiana, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Biolab Research, LLC
🇺🇸Rockville, Maryland, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Nephrology Educational Services and Research, Inc.
🇺🇸Tarzana, California, United States
Miami Kidney Group
🇺🇸Miami, Florida, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
ICSL Clinical Studies
🇺🇸Sarasota, Florida, United States
Kidney Associates
🇺🇸Houston, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
The Rogosin Institute
🇺🇸New York, New York, United States
Dialysis Clinic, Inc.
🇺🇸Cincinnati, Ohio, United States
Tucson Therapeutic Research Institute, Inc.
🇺🇸Tucson, Arizona, United States
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Phoenix Internal Medicine Associates
🇺🇸Waterbury, Connecticut, United States
Genesis Clinical Research Corporation
🇺🇸Tampa, Florida, United States
Ochsner Clinic Chronic Dialysis
🇺🇸New Orleans, Louisiana, United States