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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00048451
First received: October 31, 2002
Last updated: July 31, 2006
Last verified: July 2006
  Purpose

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 Intervention Phase
Renal Insufficiency, Chronic
Drug: paricalcitol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Estimated Enrollment: 68
Study Start Date: February 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048451

Locations
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
Poland
Wojskowy Instytut Medyczny
Warszawa, Poland
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Williams, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048451     History of Changes
Other Study ID Numbers: 2001-020
Study First Received: October 31, 2002
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014