Beginning of Effective and Safe Treatment in Immunoglobulin A Nephropathy-1 (BEST-IgAN-1) Study A randomized, double blinded, placebo-controlled, multicenter, Phase III study to evaluate the efficacy and safety of Losartan in Early Immunoglobulin A nephropathy (IgAN) patients

Ewha Womans University Medical Center0 个研究点目标入组 174 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1) Age >= 19 years
•2) Biopsy-proven IgAN
•3) Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
•4) Estimated glomerular filtration rate (by CKD-EPI) >= 60 mL/min/1.73m2 at visit 1
•5) People who voluntarily agreed to participate in the clinical trial
•6) People who understand the whole process of the trial and cooperative to it, and who can participate in the trial at the end

•1) Prevalent Hypertension:
•- hypertension dianosed previously by physician
•- taking anti-hypertensive drugs
•- systolic blood pressure >=140 mmHg and >=90 mmHg,
•2) Prevalent Diabetes:
•- diabetes dianosed previously by physician
•- taking insulin or antidiabetic drugs
•- fasting glucose >= 126 mg/dL, HbA1c >= 6.5%
•3) Previous immunosuppressive drugs use to treat IgAN
•4) Secondary IgAN
•5). Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients
•- ischemic heart disease (angina pectoris, myocardial infarction)
•- congestive heart failure
•6) hypersensitivity to RASI
•7) Other significant liver, gastrointestinal, and other autoimmune disease
•8) malignancy within 5 years
•9) Pregnancy or woman of childbearing age who don't want to use any contraceptive measure
•10) symptomatic orthostatic hypotension
•11) People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
•12) Inappropriate people ascertained by the investigator

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