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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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00062699
First received: June 11, 2003
Last updated: July 31, 2006
Last verified: July 2006
History of Changes
  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
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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062699

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

No publications provided

ClinicalTrials.gov 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
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcitriol
Vitamins
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013