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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ...).
研究组 & 干预措施
group 2
group 2 : PTH 1-84 complete (PAC) report and CAP / PTH 7-84 (CIP), Duo PTH IRMA Scantibodies
干预措施: Determination of PTH following: (Other)
group 1
group 1 : Roche Elecsys intact PTH
干预措施: Determination of PTH following (Other)
结局指标
主要结局
improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH
时间窗: 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.
次要结局
未报告次要终点