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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Drug: paricalcitol

• Study Type: Interventional
• Enrollment: 68
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Laura Williams, M.D., Abbott

Study record dates

Study Major Dates

• Study Start: February 1, 2002

Study Registration Dates

• First Submitted: October 31, 2002
• First Submitted That Met QC Criteria: November 1, 2002
• First Posted (Estimate): November 4, 2002

Study Record Updates

• Last Update Posted (Estimate): August 15, 2006
• Last Update Submitted That Met QC Criteria: August 10, 2006
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2001-019