Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism

• Registration Number: NCT00307840
• Lead Sponsor: Papageorgiou General Hospital

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 Description

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).

Study Timeline

• Study Start: 2005-02
• Study Completion: 2005-07
• Status Verified: 2005-08
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Last Update Submitted: 2006-03-27
• Study First Posted: 2006-03-28
• Last Update Posted: 2006-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-maintenance hemodialysis therapy (3 sessions per week) for at least 3 months; iPTH between 300 and 900 pg/mL; age > 18 years; normal serum calcium concentration (8.1 - 10.4 mg/dL); Ca x P product less than 70; no vitamin D metabolite replacement therapy for at least one month prior to the enrollment; aluminum levels lower than 60 μg/L.

Exclusion Criteria

administration of calcitonin, disphosphonates or corticosteroids; presence of a clinically serious medical condition; previous parathyroidectomy; active malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome was the achievement of desired iPTH levels (150 - 300 pg/mL) in the two groups (iPTH/80 and iPTH/120).

Secondary Outcome Measures

Name	Time	Method
The frequency of over-suppression of iPTH (< 150 pg/mL) was the secondary outcome.