Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

Completed · Phase 3

Conditions studied: Renal Insufficiency, Chronic

In brief

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.

Key facts

Study ID

NCT00048438

Run by

Abbott

People needed

68

Starts

2002-02-01

Last updated by the study team

2006-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCI Medical Center — Orange, California, United States
• Western Nephrology — Thornton, Colorado, United States
• Outcomes Research International, Inc. — Hudson, Florida, United States
• Nephrology Association of South Miami — Miami, Florida, United States
• Tampa Bay Nephrology Associates — Tampa, Florida, United States
• Northwestern University Medical School — Chicago, Illinois, United States
• University of Missouri Health Sciences Center — Columbia, Missouri, United States
• Arms, Dodge, Robinson, Wilber and Crouch — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• NEA Research — Las Vegas, Nevada, United States
• North Shore University Hospital — Great Neck, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Wake Nephrology Associates, PA — Raleigh, North Carolina, United States
• Kidney and Hypertension Center — Cincinnati, Ohio, United States
• Dorn VA Hospital — Columbia, South Carolina, United States
• Dallas Nephrology Associates — Dallas, Texas, United States
• The Vancouver Clinic, Inc., P.S. — Vancouver, Washington, United States
• Jagiellonian University — Cracow, Poland

Full record on ClinicalTrials.gov

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