Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy

National Center for Research Resources (NCRR)0 个研究点目标入组 43 人开始时间: 2000年5月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 43

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

OBJECTIVES: I. Determine the most sensitive outcome measures (functional or morphological) of a progressive renal injury in patients with IgA nephropathy.

II. Determine which of these patients are destined to progress to further injury in order to target them for therapy.

III. Elucidate the determinants of progression in those patients who exhibit evidence of either increasing impairment of ultrafiltration capacity or ongoing destruction of nephrons.

详细描述

PROTOCOL OUTLINE: Patients receive oral enalapril daily. Treatment continues for 5 years in the absence of unacceptable toxicity.

Patients undergo renal function studies every 6-12 months for 5 years. Patients undergo renal biopsy at 36-48 months after study entry.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 13 Years 至 60 Years（Child, Adult）
性别: All
接受健康志愿者: 是

入选标准

•Histologically confirmed IgA nephropathy, diagnosed within the past 3 years
•Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR
•Acute nephritic or nephrotic syndrome
•No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver
•No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage
•No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome)
•Healthy volunteers will be accrued as a control group
•No other concurrent medical or psychiatric illness that would preclude study

排除标准

未提供

研究者

发起方

National Center for Research Resources (NCRR)

申办方类型

Nih

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