Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1
NCT03357653 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2017-11-30
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.
Conditions
- Glomerulonephritis, Immunoglobulin A (IgA)
Interventions
- DRUG
-
Losartan group
Losartan 50 mg daily
- DRUG
-
Placebo group
Placebo 1 pill daily
Sponsors & Collaborators
-
The Catholic University of Korea
collaborator OTHER -
Kyung Hee University Hospital at Gangdong
collaborator OTHER -
Kyungpook National University Hospital
collaborator OTHER -
Korea University Guro Hospital
collaborator OTHER -
SMG-SNU Boramae Medical Center
collaborator OTHER -
Seoul National University Bundang Hospital
collaborator OTHER -
Seoul National University Hospital
collaborator OTHER -
Ajou University School of Medicine
collaborator OTHER -
Pusan National University Yangsan Hospital
collaborator OTHER -
Severance Hospital
collaborator OTHER -
Eulji General Hospital
collaborator OTHER -
National Health Insurance Service Ilsan Hospital
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
Chonbuk National University Hospital
collaborator OTHER -
Kangdong Sacred Heart Hospital
collaborator OTHER -
Hallym University Medical Center
collaborator OTHER -
Gangnam Severance Hospital
collaborator OTHER -
Ewha Womans University
lead OTHER
Principal Investigators
-
Dong-Ryeol Ryu, Professor · Ewha Womans University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-30
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
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