Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02859220
Brief 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.
Study:
NCT02859220
Study Brief:
Protocol Section:
NCT02859220