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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Other: Determination of PTH following
* Other: Determination of PTH following:


Participation Criteria
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Eligibility Criteria
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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 ...).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1<br>group 1 : Roche Elecsys intact PTH | Other: Determination of PTH following<br>* Determination of PTH following: in group 1: intact PTH Elecsys Roche<br>|
| Other: group 2<br>group 2 : PTH 1-84 complete (PAC) report and CAP / PTH 7-84 (CIP), Duo PTH IRMA Scantibodies | Other: Determination of PTH following:<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, PTH