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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.
First Received: June 11, 2003   Last Updated: July 31, 2006   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00062699
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Study ID Numbers: M02-516
Study First Received: June 11, 2003
Last Updated: July 31, 2006
ClinicalTrials.gov Identifier: NCT00062699     History of Changes
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2009