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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00048516
First received: November 1, 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 capsule
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 (Daily Dosing)

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 in 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 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
  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: NCT00048516

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles
Los Angeles, California, United States, 90073
Nephrology Associates Medical Group
Riverside, California, United States, 92501
Kidney Center, Inc.
Simi Valley, California, United States, 93065
United States, Colorado
Denver Nephrologists
Denver, Colorado, United States, 80220
University of CO Health Sciences Center
Denver, Colorado, United States, 80262
United States, Iowa
Dialysis PC
Des Moines, Iowa, United States, 50309
United States, Minnesota
Twin Cities Clinical Research
Arden Hills, Minnesota, United States, 55126
United States, New York
Long Island College Hospital
Brooklyn, New York, United States, 11201
Erie County Medical Center
Buffalo, New York, United States, 14215
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Avera McKennan Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Nephrology Associates
Nashville, Tennessee, United States, 37205
United States, Texas
San Antonio Kidney Disease Research Center
San Antonio, Texas, United States, 78219
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Washington
FHS Research Center
Tacoma, Washington, United States, 98405
Poland
Wojewodzki Szpital Specjalistyczny AM w Bialymstoku
Bialymstoku, Poland
Krakow Hospital
Krakow, Poland
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Williams, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048516     History of Changes
Other Study ID Numbers: 2001-021
Study First Received: November 1, 2002
Last Updated: July 31, 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 August 21, 2014