Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

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

NCT00048516

Run by

Abbott

People needed

68

Starts

2002-02-01

Last updated by the study team

2006-08-02

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 months 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

• VA Greater Los Angeles Healthcare System, West Los Angeles — Los Angeles, California, United States
• Nephrology Associates Medical Group — Riverside, California, United States
• Kidney Center, Inc. — Simi Valley, California, United States
• Denver Nephrologists — Denver, Colorado, United States
• University of CO Health Sciences Center — Denver, Colorado, United States
• Dialysis PC — Des Moines, Iowa, United States
• Twin Cities Clinical Research — Arden Hills, Minnesota, United States
• Long Island College Hospital — Brooklyn, New York, United States
• Erie County Medical Center — Buffalo, New York, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Avera McKennan Research Institute — Sioux Falls, South Dakota, United States
• Nephrology Associates — Nashville, Tennessee, United States
• San Antonio Kidney Disease Research Center — San Antonio, Texas, United States
• Clinical Research Associates of Tidewater — Norfolk, Virginia, United States
• FHS Research Center — Tacoma, Washington, United States
• Wojewodzki Szpital Specjalistyczny AM w Bialymstoku — Bialymstoku, Poland
• Krakow Hospital — Krakow, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.