Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-07-31

Brief Summary

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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

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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).

Conditions

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Secondary Hyperparathyroidism

Keywords

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hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paricalcitol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Efstathios Mitsopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Papageorgiou General Hospital, Thessaloniki, Greece

References

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Martin KJ, Gonzalez E, Lindberg JS, Taccetta C, Amdahl M, Malhotra K, Llach F. Paricalcitol dosing according to body weight or severity of hyperparathyroidism: a double-blind, multicenter, randomized study. Am J Kidney Dis. 2001 Nov;38(5 Suppl 5):S57-63. doi: 10.1053/ajkd.2001.28112.

Reference Type BACKGROUND

PMID: 11689389 (View on PubMed)

Other Identifiers

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48/4-2-2005

Identifier Type: -

Identifier Source: org_study_id