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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.
 
ClinicalTrials.gov Identifier: NCT00048438
Recruitment Status : Completed
First Posted : November 4, 2002
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE October 31, 2002
First Posted Date  ICMJE November 4, 2002
Last Update Posted Date August 15, 2006
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)		 The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
Official Title  ICMJE Safety and Efficacy of Zemplar Capsule in Reducing Serum IPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Renal Insufficiency, Chronic
Intervention  ICMJE Drug: paricalcitol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		 68
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00048438
Other Study ID Numbers  ICMJE 2001-019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Laura Williams, M.D. Abbott
PRS Account Abbott
Verification Date August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP