NCT02859220

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)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis Patients

Interventions

Type	Name	Description
OTHER	Determination of PTH following	Determination of PTH following: in group 1: intact PTH Elecsys Roche
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2016-08-09
• Last updated: 2016-08-09