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Sponsored by: |
Abbott |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00073710 |
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 |
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
Study ID Numbers: | M01-375 |
Study First Received: | December 3, 2003 |
Last Updated: | July 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00073710 |
Health Authority: | United States: Food and Drug Administration |
secondary hyperparathyroidism |
Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Endocrine System Diseases Calcitriol Calcium, Dietary Hyperparathyroidism, Secondary |
Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Neoplasm Metastasis Kidney Diseases Endocrinopathy Kidney Failure |
Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Neoplastic Processes Neoplasms Pathologic Processes Therapeutic Uses Vitamins Vasoconstrictor Agents Micronutrients |