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

July 31, 2006 updated by: Abbott
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

Intervention / Treatment

Study Type

Interventional

Enrollment

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 in iPTH levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Registration Dates

First Submitted

November 1, 2002

First Submitted That Met QC Criteria

November 1, 2002

First Posted (Estimate)

November 4, 2002

Study Record Updates

Last Update Posted (Estimate)

August 2, 2006

Last Update Submitted That Met QC Criteria

July 31, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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