Clinical Trial: Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism

Brief Summary: 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)

Detailed Summary: 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).
Sponsor: Papageorgiou General Hospital

Current Primary Outcome: The primary outcome was the achievement of desired iPTH levels (150 - 300 pg/mL) in the two groups (iPTH/80 and iPTH/120).

Original Primary Outcome: Same as current

Current Secondary Outcome: The frequency of over-suppression of iPTH (< 150 pg/mL) was the secondary outcome.

Original Secondary Outcome: Same as current

Information By: Papageorgiou General Hospital

Dates:
Date Received: March 27, 2006
Date Started: February 2005
Date Completion: July 2005
Last Updated: March 27, 2006
Last Verified: August 2005