Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism
The purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the already in use iPTH/80 scheme, and an iPTH/120 scheme, which corresponds to the immediately lower dose, based on current instructions on paricalcitol dose adjustment. We studied the effectiveness of the two dosing schemes in achieving a target iPTH level (150 – 300 pg/mL)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism|
- The primary outcome was the achievement of desired iPTH levels (150 - 300 pg/mL) in the two groups (iPTH/80 and iPTH/120).
- The frequency of over-suppression of iPTH (< 150 pg/mL) was the secondary outcome.
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||July 2005|
Adjustment of the initial dose of paricalcitol, in hemodialysis patients with secondary hyperparathyroidism (sHPT), on the basis of severity of sHPT is generally preferred in current practice. Whether the proposed dose, based on the formula baseline intact parathyroid hormone (iPTH [pg/mL]) divided by 80, is the most appropriate has not been adequately assessed. A trial comparing the iPTH/80 dose to the immediately lower iPTH/120 dose was undertaken. We studied the ability of the two different dosing schemes to control iPTH levels within a desired range between 150 and 300 pg/mL, as well as the frequency of iPTH over-suppression (< 150 pg/mL) in the two groups (iPTH/80 and iPTH/120).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307840
|Principal Investigator:||Efstathios Mitsopoulos, MD||Papageorgiou General Hospital, Thessaloniki, Greece|