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:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Calcitriol 19-Nor-1alpha,25-dihydroxyvitamin D2

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

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