Kidney Disease Clinical Trial
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 Dialysis Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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