Overview

Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

Status:
Completed

Trial end date:
2005-07-01

Target enrollment:
0

Participant gender:
All

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)

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Papageorgiou General Hospital

Treatments:

Ergocalciferols

Criteria

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.

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

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