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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357653 on ClinicalTrials.gov