NCT00307840

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
Last Updated

March 28, 2006

Status Verified

August 1, 2005

First QC Date

March 27, 2006

Last Update Submit

March 27, 2006

Conditions

Secondary Hyperparathyroidism

Keywords

hemodialysis; secondary hyperparathyroidism; hypercalcemia; hyperphosphatemia; vitamin D

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

paricalcitolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 11689389BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryHypercalcemiaHyperphosphatemia

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalancePhosphorus Metabolism Disorders

Study Officials

  • Efstathios Mitsopoulos, MD

    Papageorgiou General Hospital, Thessaloniki, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

February 1, 2005

Study Completion

July 1, 2005

Last Updated

March 28, 2006

Record last verified: 2005-08