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Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00062699
First Posted: June 13, 2003
Last Update Posted: August 2, 2006
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.
Information provided by:
Abbott
  Purpose
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.

Condition Intervention Phase
End-Stage Kidney Disease Drug: Zemplar (paricalcitol injection) Drug: Calcijex Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects With Stage V Chronic Kidney Disease on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Time to Death

Secondary Outcome Measures:
  • Time to Death attributable to cardiovascular disease
  • Number of hospitalizations for any cause
  • Number of hospitalizations due to cardiovascular disease
  • Number of days hospitalized for any cause
  • Number of days hospitalized due to cardiovascular disease

Estimated Enrollment: 2200
Study Start Date: April 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00062699


  Show 60 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information

ClinicalTrials.gov Identifier: NCT00062699     History of Changes
Other Study ID Numbers: M02-516
First Submitted: June 11, 2003
First Posted: June 13, 2003
Last Update Posted: August 2, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents