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  

Hemodialysis Patients Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemodialysis Patients

• NCT number: NCT02859220
• Study type: Interventional
• Source: Nantes University Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Completion date: January 2011