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 Dialysis Patients
Overview
- Phase
- N/A
- Intervention
- Paricalitol
- Conditions
- Hyperparathyroidism
- Sponsor
- Penang Hospital, Malaysia
- Enrollment
- 69
- Locations
- 11
- Primary Endpoint
- More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr.Ong Loke Meng
Consultant Nephrologist
Penang Hospital, Malaysia
Eligibility Criteria
Inclusion Criteria
- •Age at or above 18 years
- •End stage renal disease on regular maintenance haemodialysis or peritoneal dialysis for at least 3 months
- •iPTH level of 300 pg/ml or greater at baseline
- •Written informed consent by subject or guardian
- •Female patients will either be post-menopausal for more than 2 years, surgically sterile or if of childbearing age, using double contraception
Exclusion Criteria
- •Baseline calcium value more than 2.87 mmol/L
- •Baseline Ca x P of greater than 5.63 mmol2/l2
- •Positive for HBsAg or Hepatitis C with raised ALT twice above upper limit of normal or evidence of liver cirrhosis
- •Clinically significant gastrointestinal disease
- •History of allergic reaction to calcitriol or other vitamin D compounds
- •Inability or unwillingness to provide written consent.
- •Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- •Pregnancy, breastfeeding or use of non-reliable method of contraception.
- •Use of medications prohibited prior to randomization such as ketoconazole and other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir
- •Necessity for calcitonin, biphosphonates, maintenance oral or intravenous glucocorticoid or cinacalcet or other drugs that may affect calcium or bone metabolism.
Arms & Interventions
1
Oral Paricalcitol in varying doses
Intervention: Paricalitol
2
Calcitriol
Intervention: Calcitriol
Outcomes
Primary Outcomes
More than 30% reduction in baseline iPTH concentration at 24 weeks of treatment with Paricalcitol or Calcitriol capsules.
Time Frame: 24 weeks
Secondary Outcomes
- Incidence of hypercalcaemic episodes(Through out 24 weeks of participation from the time of enrollment)
- Quantum of reduction in alkaline phosphatase level, Time duration to achieve the target level of iPTH. (Titration time), Serum Calcium, phosphate, Ca x Po4 product change from baseline(24 weeks)