Study of the Influence of Dosages of 1-84 and 7-84 Fragments of Parathyroid Hormone Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis (PTH) (PTH)

August 3, 2016 updated by: Nantes University Hospital

Study of the Influence of Dosages of 1-84 and 7-84 Fragments of PTH Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis

This study included 80 patients with end stage renal disease requiring dialysis treatment to evaluate two techniques for the determination of parathyroid hormone (PTH)

Objective: To evaluate whether the monitoring of hemodialysis patients by measurement of PTH 1-84 Complete (CAP =cyclase activating PTH) and the ratio (1-84 PTH (CAP)/7-84 PTH (CIP = cyclase inactivating PTH) with kit "Duo PTH Immunoradiometric Scantibodies" allows an improvement in the therapeutic management of abnormal calcium and phosphate, with a better match to the targets of current international recommendations, followed by the conventional intact PTH assay.

Primary endpoint:

For each patient, a score will be awarded based on the number of criteria (including calcium, phosphorus and calcium phosphate product) in the target international guidelines :0-1-2 or 3.

The primary endpoint will be the average scores in both groups at the beginning and the end of the study,

Main secondary endpoints:

  • Changes in the number of patients responding to international guidelines for each of the three parameters studied (serum phosphate, corrected calcium, phosphorus product) in the 2 groups,
  • Evolution of Elecsys intact PTH Roche in the 2 groups,
  • Salaries and changes in the number of drugs to normalize the phospho-calcium balance in each group received,
  • cardiovascular events (morbidity and cardiovascular mortality),
  • Total mortality.

Statistical analysis:

This is a randomized, two parallel arms. The investigators will compare the average number of criteria on calcium and phosphate in the target according to a Mann-Whitney. The analysis will be performed with the software Splus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • replacement therapy by hemodialysis for at least three months in the hemodialysis center of Nantes University Hospital,
  • intact PTH ≥ 100 pg / mL during the visit of inclusion.

Exclusion Criteria:

  • intact PTH <100 pg / mL during the visit of inclusion
  • Life expectancy estimated at less than one year at the time of inclusion, because of a disease diagnosed prior to the initiation of the study,
  • bone pathology diagnosed prior to the initiation of the study that interfere with calcium and phosphate metabolism (myeloma, Paget ...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group 1
group 1 : Roche Elecsys intact PTH
Other: Determination of PTH following

Determination of PTH following:

in group 1: intact PTH Elecsys Roche
Other: group 2
group 2 : PTH 1-84 complete (PAC) report and CAP / PTH 7-84 (CIP), Duo PTH IRMA Scantibodies
Other: Determination of PTH following:
PTH 1-84 complete (PAC) report and CAP / CIP, the package "Duo PTH IRMA Scantibodies." The CIP is obtained by calculating the difference between total intact PTH and PTH 1-84 in the kit used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH
Time Frame: one year

Show that patients receiving a dose of complete PTH 1-84 (CAP) and the ratio PTH 1-84/7-84 more easily reach the objectives international guidelines on the three following parameters calcium and phosphate: phosphorus, corrected calcium and phosphorus product.

For each patient, a score will be awarded based on the number of criteria (including calcium, phosphorus and calcium phosphate product) in the target international guidelines:0-1-2 or 3.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRD/05/12-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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