A clinical trial to evaluate the effect of Losartan in early IgA nephropathy patients

Not Applicable

Terminated

• Conditions: Diseases of the genitourinary system

• Registration Number: KCT0002916
• Lead Sponsor: Ewha Womans University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 174

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant proteinuria rate [ Time Frame: 144 weeks after study started ]; Random urine protein-to-creatinine ratio >= 1g/g creatinine