临床试验/NCT00617474

NCT00617474Unknown1 期

The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

Labbafinejhad Hospital0 个研究点目标入组 50 人开始时间: 2008年3月最近更新: 2008年3月28日

适应症

干预措施

试验速览

阶段: 1 期
发起方
入组人数: 50
主要终点: We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Hb: >8 and <10 gr/dl
•Age: >18 and <55 years
•Cholesterol: <300 mg/dl
•Triglyceride: <400 mg/dl
•First Transplantation
•Protocol of Immunosuppression: CSA + MMF + Prednisolone
•Systolic BP: <14
•Diastolic BP: <9

排除标准

•History of specified cardiac disease
•Second Transplantation or more
•Hb: <7gr/dl
•The patient needs to infusion of blood
•Evidence of local or systemic infection, at the time of EPO injection
•Presence of ATN / DGF after transplantation
•Presence of emergent hypertension
•High risk patients ( Like; PRA>50%)
•Past history of hypersensitivity

研究组 & 干预措施

1

Experimental

Group of patient with anemia, that treated by erythropoietin

干预措施: Erythropoietin (Drug)

2

Placebo Comparator

Patients group with anemia that treated by placebo

干预措施: Placebo (Drug)

结局指标

主要结局

We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival.

时间窗: May,2008

次要结局

未报告次要终点

研究者

发起方

Labbafinejhad Hospital

申办方类型

Other

相似试验

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不适用

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2 期

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不适用

EFFECT OF ERYTHROPOIETIN ON RENAL FUNCTION AFTER KIDNEY TRANSPLANTATION - EPO AND ISCHEMIA-REPERFUSION AFTER KIDNEY TRANSPLANTATIOWe will investigate the effect of recombinant human erythropoietin (rHuEPO) on ischemia-reperfusion injury in patients with terminal renal failure undergoing cadaveric kidney transplantation. In this clinical setting rHuEPO is expected to have anti-apoptotic tissue protective effects.

EUCTR2006-002938-38-DEHannover Medical School