NCT03357653

Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Losartan group	Losartan 50 mg daily
DRUG	Placebo group	Placebo 1 pill daily

Timeline

• Start date: 2018-01-30
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-11-30
• Last updated: 2017-11-30