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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00073710 |
Purpose
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism Chronic Kidney Disease |
Drug: Zemplar Procedure: 42 Ca carbonate absorption via single tracer method Drug: Calcijex |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
Exclusion Criteria
Contacts and Locations
More Information
| Study ID Numbers: | M01-375 |
| Study First Received: | December 3, 2003 |
| Last Updated: | July 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00073710 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
secondary hyperparathyroidism |
|
Parathyroid Diseases Renal Insufficiency Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Agonists Kidney Failure, Chronic Bone Density Conservation Agents Calcitriol Membrane Transport Modulators Neoplastic Processes Hyperparathyroidism, Secondary Pathologic Processes Urologic Diseases Therapeutic Uses |
Vitamins Neoplasm Metastasis Vasoconstrictor Agents Kidney Diseases Micronutrients Growth Substances Endocrine System Diseases Cardiovascular Agents Pharmacologic Actions Neoplasms Hyperparathyroidism Renal Insufficiency, Chronic Kidney Failure |