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Sponsors and Collaborators: |
Penang Hospital, Malaysia Ministry of Health, Malaysia |
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Information provided by: | Penang Hospital, Malaysia |
ClinicalTrials.gov Identifier: | NCT00800358 |
The purpose of this study is to determine whether oral paricalcitol is safer and more efficacious compared to oral calcitriol in the treatment of hyperparathyroidism in chronic kidney disease patients undergoing dialysis.
Condition | Intervention |
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Hyperparathyroidism Kidney Disease |
Drug: Paricalitol Drug: Calcitriol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi Centre, Open Label, Parallel Group, Randomized Controlled Trial to Compare the Safety and Efficacy of Oral Paricalcitol Versus Oral Calcitriol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Patients Undergoing Dialysis. |
Estimated Enrollment: | 60 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Paricalcitol
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Drug: Paricalitol
oral paricalcitol variable daily dosing based on intact PTH level for 6 months
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2: Active Comparator
Calcitriol
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Drug: Calcitriol
oral calcitriol variable daily dosing based on intact PTH level for 6 months
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Secondary hyperparathyroidism, a common consequence of chronic kidney disease, results from abnormal regulation of calcium and phosphate homeostasis. The early administration of calcium supplements or vitamin D attenuates the development and progression of hyperparathyroidism, preventing or retarding the emergence of many of the serious complications of chronic kidney disease. However, these vitamin D derivatives also have serious side effects, including hypercalcemia and hyperphosphatemia and, as a result, a high level of the calcium-phosphate product. These adverse outcomes have prompted the development of novel, "nonhypercalcemic" vitamin D analogues. Three of these analogues have recently been marketed for clinical use in patients with chronic kidney disease: 19-nor-1,25-dihydroxyvitamin D2 (paricalcitol), 1 -hydroxyvitamin D2 (doxercalciferol), and 22-oxacalcitriol.
Oral paricalcitol was developed to provide a convenient, alternative therapy, particularly for Peritoneal Dialysis patients in whom regular intravenous administration of paricalcitol is not practical. This study is designed to determine the proportion of patients with 'End stage renal failure' on haemodialysis or peritoneal dialysis and secondary hyperparathyroidism who achieved more than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Malinee Neelamegam | 00 604 2225762 | malinee@crc.gov.my |
Contact: Salawati Saedin | 00 604 2225765 | salawati@crc.gov.my |
Malaysia | |
Haemodialysis Unit, Melaka Hospital | |
Melaka, Malaysia, 75400 | |
Malaysia, Kelantan | |
Hemodialysis Unit, Raja Perempuan Zainab II Hospital | |
Kota Bahru, Kelantan, Malaysia, 15586 | |
Malaysia, Pahang | |
Hemodialysis Unit, Tengku Ampuan Afzan Hospital | |
Kuantan, Pahang, Malaysia, 25100 | |
Malaysia, Penang | |
Clinical Research Centre, Penang Hospital | |
Georgetown, Penang, Malaysia, 10990 | |
Haemodialysis Unit, Seberang Jaya Hospital | |
Seberang jaya, Penang, Malaysia, 13700 | |
Malaysia, Perak | |
Hemodialysis Unit, Taiping Hospital | |
Taiping, Perak, Malaysia, 34000 | |
Haemodialysis Unit, Ipoh Hospital | |
Ipoh, Perak, Malaysia, 30990 | |
Malaysia, Perlis | |
Haemodialysis Unit, Sultanah Bahiyah Hospital | |
Alor Setar, Perlis, Malaysia, 05460 | |
Malaysia, Selangor | |
Hemodialysis Unit, Kuala Lumpur Hospital | |
Kuala Lumpur, Selangor, Malaysia, 50586 | |
Haemodialysis Unit, Serdang Hospital | |
Serdang, Selangor, Malaysia, 43000 | |
Nephrology Department, Tengku Ampuan Rahimah Hospital | |
Klang, Selangor, Malaysia, 41200 | |
Hemodialysis Unit, Tuanku Ja'afar Seremban Hospital | |
Seremban, Selangor, Malaysia, 70300 |
Principal Investigator: | Ong L Meng, MBBS, MRCP | Clinical Research Centre, Penang Hospital |
Responsible Party: | Penang Hospital, Ministry of Health, Malaysia ( Dr. Ong Loke Meng, Consultant Nephrologist ) |
Study ID Numbers: | Protocol No: CT 08-02 |
Study First Received: | November 30, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00800358 |
Health Authority: | Malaysia : Medical Research Ethics Committee; Malaysia : Drug Control Authority (DCA) |
Secondary hyperparathyroidism End stage renal disease Haemodialysis Peritoneal dialysis |
Paricalcitol (Zemplar) Calcitriol Secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis. |
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 |