Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048451
Recruitment Status : Completed
First Posted : November 4, 2002
Last Update Posted : August 2, 2006
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: paricalcitol Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
Study Start Date : February 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048451

Layout table for location information
United States, Arizona
Tucson Therapeutic Research Institute, Inc.
Tucson, Arizona, United States, 85712
United States, California
Pasadena, California, United States, 91105
California Institute of Renal Research
San Diego, California, United States, 92120
Nephrology Educational Services and Research, Inc.
Tarzana, California, United States, 91356
United States, Connecticut
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States, 06708
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Miami Kidney Group
Miami, Florida, United States, 33143
ICSL Clinical Studies
Sarasota, Florida, United States, 34232
Genesis Clinical Research Corporation
Tampa, Florida, United States, 33614
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
United States, Indiana
Medisphere Medical Research Center
Evansville, Indiana, United States, 47714
United States, Louisiana
Ochsner Clinic Chronic Dialysis
New Orleans, Louisiana, United States, 70121
United States, Maryland
Biolab Research, LLC
Rockville, Maryland, United States, 20852
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
United States, Ohio
Dialysis Clinic, Inc.
Cincinnati, Ohio, United States, 45206
United States, Texas
Kidney Associates
Houston, Texas, United States, 77030
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79430
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Wojskowy Instytut Medyczny
Warszawa, Poland
Sponsors and Collaborators
Layout table for investigator information
Study Director: Laura Williams, M.D. Abbott

Layout table for additonal information Identifier: NCT00048451     History of Changes
Other Study ID Numbers: 2001-020
First Posted: November 4, 2002    Key Record Dates
Last Update Posted: August 2, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases