None listed
Conditions
Interventions
Drug : In this study, the participants will take investigational product (IP
Losartan 50 mg or placebo) once in the morning daily with other medication regularly for 144 weeks. The investigators will evaluate the decrease in the proteinuria amount every visit, and they can dou
Sponsors
Ewha Womans University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 - others 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant proteinuria rate [ Time Frame: 144 weeks after study started ]; Random urine protein-to-creatinine ratio >= 1g/g creatinine | — |
Secondary
| Measure | Time frame |
|---|---|
| Proteinuria remission rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ]; Random urine protein-to-creatinine ratio = 40% from the baseline value;Hypertension development rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ]; Systolic blood pressure >= 140 or diastolic blood pressure >= 90;Mean eGFR change [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Mean UPCR change [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];eGFR change rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];UPCR change rate [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Difference between eGFR change slope [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Difference between UPCR change slope [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Difference between eGFR [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Difference between UPCR [ Time Frame: 48 weeks, 96 weeks, and 144 weeks after study ];Difference in proteinuria-progression free survival until the development of Spot UPCR =1.0g/g cr;Difference in proteinuria-remission time (Spot UPCR< 0.2 g/g cr);Difference in CKD-progression free survival (eGFR < 40%);Difference in hypertension free survival;Difference in Composite outcome rate (event-free survival of composit of eGFR =40% decline, Increase in Spot UPCR =1.0g/g cr, or Incident hypertension);Adverse drug reaction, Laboratory result (hematologic/chemistry, urinalysis), physical examination, orthostatic hypotension, change in weight and pulse | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Ryeol Ryu
Ewha Womans University Medical Center
Outcome results
None listed