Clinical Trial: A Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in Patients With Stage 5 Chronic Kidney Disease

This study is not yet open for patient recruitment.
Verified by Abbott Laboratories November 2005

Sponsored by: Abbott Laboratories
Information provided by: Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00257920

Purpose

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in subjects on hemodialysis
Condition Intervention Phase
Stage 5 Chronic Kidney Disease (CKD)
Secondary Hyperparathyroidism
 Drug: Zemplar® Injection
 Drug: Hectorol® Injection
 Procedure: 42 Calcium Carbonate absorption via single tracer method
Phase IV

MedlinePlus related topics:  Kidney Diseases;   Parathyroid Disorders
Genetics Home Reference related topics:  Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment

Eligibility

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Stage 5 CKD patients on hemodialysis three times a week for at least 2 months iPTH level > 200 pg/mL calcium level < 10.2 mg/dL phosphorus level< 6.5 mg/dL CaxP product level < 65 hemoglobin level greater than or equal to 9.0 g/dL

Exclusion Criteria:

No liver function defects No drugs affecting calcium or bone metabolism

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00257920

Jamie (Stob) Vujasin, B.S.      847-936-3103    jamie.stob@abbott.com

Nebraska
      Creighton University Medical Center/Dialysis Clinic, Inc., Omaha,  Nebraska,  68131,  United States
Jina Bogle, R.N.  402-341-3141    jinabogle@creighton.edu 
Richard Lund, M.D.,  Principal Investigator

      Creighton University Medical Center/Dialysis Clinic, Inc., Bellevue,  Nebraska,  68123,  United States
Jina Bogle, R.N.  402-341-3141    jinabogle@creighton.edu 
Richard Lund, M.D.,  Principal Investigator

Study chairs or principal investigators

Richard Lund, M.D.,  Principal Investigator,  Creighton University Medical Center   

More Information

Study ID Numbers:  M04-726
Last Updated:  December 8, 2005
Record first received:  November 22, 2005
ClinicalTrials.gov Identifier:  NCT00257920
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10

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