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:
NCT00048438
First received: October 31, 2002
Last updated: August 10, 2006
Last verified: August 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: NCT00048438

Locations
United States, California
UCI Medical Center
Orange, California, United States, 92868
United States, Colorado
Western Nephrology
Thornton, Colorado, United States, 80260
United States, Florida
Outcomes Research International, Inc.
Hudson, Florida, United States, 34667
Nephrology Association of South Miami
Miami, Florida, United States, 33173
Tampa Bay Nephrology Associates
Tampa, Florida, United States, 33603
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
United States, Missouri
University of Missouri Health Sciences Center
Columbia, Missouri, United States, 65212
Arms, Dodge, Robinson, Wilber and Crouch
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
NEA Research
Las Vegas, Nevada, United States, 89102
United States, New York
North Shore University Hospital
Great Neck, New York, United States, 11021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States, 27609
United States, Ohio
Kidney and Hypertension Center
Cincinnati, Ohio, United States, 45220
United States, South Carolina
Dorn VA Hospital
Columbia, South Carolina, United States, 29209
United States, Texas
Dallas Nephrology Associates
Dallas, Texas, United States, 75235
United States, Washington
The Vancouver Clinic, Inc., P.S.
Vancouver, Washington, United States, 98644
Poland
Jagiellonian University
Cracow, Poland
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Williams, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048438     History of Changes
Other Study ID Numbers: 2001-019
Study First Received: October 31, 2002
Last Updated: August 10, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014