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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

Study Description
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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

Study Design
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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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00048438


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Laura Williams, M.D. Abbott
More Information
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ClinicalTrials.gov Identifier: NCT00048438    
Other Study ID Numbers: 2001-019
First Posted: November 4, 2002    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases