Glomerulonephritis, Immunoglobulin A (IgA)
Conditions
Keywords
proteinuria, progression, early immunoglobulin A (IgA) nephropathy
Brief summary
Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria \>1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.
Interventions
DRUGLosartan group
Losartan 50 mg daily
DRUGPlacebo group
Placebo 1 pill daily
Sponsors
The Catholic University of Korea
Kyung Hee University Hospital at Gangdong
Kyungpook National University Hospital
Korea University Guro Hospital
SMG-SNU Boramae Medical Center
Seoul National University Bundang Hospital
Seoul National University Hospital
Ajou University School of Medicine
Pusan National University Yangsan Hospital
Severance Hospital
Eulji General Hospital
National Health Insurance Service Ilsan Hospital
Chonnam National University Hospital
Chonbuk National University Hospital
Kangdong Sacred Heart Hospital
Hallym University Medical Center
Gangnam Severance Hospital
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The investigators will test the effect of ARB to prevent the development of significant proteinuria, defined as random urine protein-to-creatinine ratio of \>1g/g creatinine. In this study, the investigators choose losartan as a testing ARB. The investigators will compare the rate of significant proteinuria development between 2 arms, namely losartan group and placebo group after 144 weeks' treatment.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain 2. Age \>= 19 years 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 \>= 60 mL/min/1.73m2 at visit 1 5. People who voluntarily agreed to participate 6. People who are compliant
Exclusion criteria
1. Prevalent Hypertension: systolic blood pressure \>=140 mmHg and \>=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs 2. Prevalent Diabetes: fasting glucose \>= 126 mg/dL, HbA1c \>= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes 3. Previous immunosuppressive drugs use to treat IgAN 4. Secondary IgAN 5. Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others) 6. hypersensitivity to RASI 7. Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease 8. Pregnancy 9. symptomatic orthostatic hypotension 10. People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit 11. Inappropriate people ascertained by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant proteinuria rate | 144 weeks after study started | Random urine protein-to-creatinine ratio \>= 1g/g creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteinuria remission rate | 48 weeks, 96 weeks, and 144 weeks after study started | Random urine protein-to-creatinine ratio \< 0.20 g/g creatinine |
| Impaired kidney function rate | 48 weeks, 96 weeks, and 144 weeks after study started | estimated glomerular filtration rate decline \>= 40% from the baseline value |
| Hypertension development rate | 48 weeks, 96 weeks, and 144 weeks after study started | Systolic blood pressure \>= 140 or diastolic blood pressure \>= 90 |
Contacts
Primary ContactDong-Ryeol Ryu, Professor
Outcome results
None listed