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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.
Information provided by:
Abbott Identifier:
First received: June 11, 2003
Last updated: July 31, 2006
Last verified: July 2006
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00062699

  Show 60 Study Locations
Sponsors and Collaborators
Study Director: Global Medical Information 1-800-633-9110 Abbott
  More Information Identifier: NCT00062699     History of Changes
Other Study ID Numbers: M02-516 
Study First Received: June 11, 2003
Last Updated: July 31, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents processed this record on October 20, 2016