Not Signed In -
Calcitriol Injection |
Calcijex |
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
|
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
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
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
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
Resources
- Calcijex (Drug Digest)
- Calcitriol Injection (Drug Digest)
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