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临床试验/NCT01290328
NCT01290328终止不适用

Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial

Mehrotra, Anita, M.D.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
100
试验地点
1
主要终点
change in hemoglobin

研究概览

简要总结

The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The investigators hypothesize that epoetin alfa will raise hemoglobin.

详细描述

Anemia has become an increasingly recognized problem in kidney transplant recipients, and erythropoietin is often prescribed as treatment despite limited data regarding outcomes. Multiple clinical trials have demonstrated correction of anemia with erythropoietin in patients with chronic kidney disease (pre-transplant) and patients on dialysis. No large clinical trials of erythropoietin treatment have been done in anemic kidney transplant recipients, however. The investigators hypothesize that when used for the treatment of post-transplant anemia, Epoetin Alfa increases hemoglobin (Hb). The investigators further hypothesize that Epoetin Alfa suppresses pathogenic alloimmunity directed at the kidney transplant and as a consequence, prevents immune-mediated injury and thereby preserves renal function. Finally, the investigators hypothesize that treatment of post-transplant anemia with Epoetin Alfa also results in improved patient-reported outcomes (quality of life) and decreased left ventricular mass. In order to test these hypotheses, the investigators propose a randomized controlled trial of Epoetin Alfa in anemic kidney transplant recipients (9.0 < Hb < 11.0). 100 study subjects will be randomized to either treatment with Epoetin Alfa at a starting dose of 150 units/kg/week or no treatment (50 subjects/arm). The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment. Secondary outcomes to be measured include change in renal function (eGFR), change in T cell phenotype, change in patient-reported outcomes (SF-36 form), and change in left ventricular mass (by cardiac MRI).

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
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

入选标准

  • Age > 18 years
  • Kidney transplant recipient at least 8 weeks post-transplant
  • Mild to moderate anemia, defined as 9.0 g/dL < Hb < 11 g/dL)
  • Estimated GFR (by MDRD) < 60 mL/min (not on dialysis)
  • Transferrin saturation > 20% and Ferritin > 100 ng/mL

排除标准

  • History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks
  • Red blood cell transfusion in previous 30 days
  • History of HIV/AIDS
  • Nonfunctioning graft, defined as patient requiring chronic dialysis
  • Hypersensitivity to ESAs or albumin
  • Uncontrolled hypertension, defined as screening BP > 180/100
  • New-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication)
  • History of any neoplasm except: adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease-free for more than 5 years.
  • Pregnancy or lactating
  • Vitamin B12 deficiency (Vit B12 < 180 pg/mL)
  • Untreated folate deficiency (folate < 6.6 ng/mL)

研究组 & 干预措施

Epoetin alfa

Experimental

150 units/kg/week

干预措施: Epoetin Alfa (Drug)

结局指标

主要结局

change in hemoglobin

时间窗: 6 weeks to 1 year

The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment.

次要结局

  • change in renal function (eGFR)(6 weeks to 1 year)

研究者

发起方
Mehrotra, Anita, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Anita Mehrotra MD

Principal Investigator

Mehrotra, Anita, M.D.

研究点 (1)

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