Beginning of Effective and Safe Treatment in Immunoglobulin A-1 Nephropathy-1 (BEST-IgAN-1)

November 28, 2017 updated by: Ewha Womans University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan group
Losartan 50 mg daily
Drug: Losartan group
Losartan 50 mg daily
Other Names:
  • Losartan
Placebo Comparator: Placebo group
Placebo 1 pill daily which has same size, color and taste with losartan
Drug: Placebo group
Placebo 1 pill daily
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant proteinuria rate
Time Frame: 144 weeks after study started
Random urine protein-to-creatinine ratio >= 1g/g creatinine
144 weeks after study started

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteinuria remission rate
Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started
Random urine protein-to-creatinine ratio < 0.20 g/g creatinine
48 weeks, 96 weeks, and 144 weeks after study started
Impaired kidney function rate
Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started
estimated glomerular filtration rate decline >= 40% from the baseline value
48 weeks, 96 weeks, and 144 weeks after study started
Hypertension development rate
Time Frame: 48 weeks, 96 weeks, and 144 weeks after study started
Systolic blood pressure >= 140 or diastolic blood pressure >= 90
48 weeks, 96 weeks, and 144 weeks after study started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Collaborators

Chonbuk National University Hospital
Chonnam National University Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Korea University Guro Hospital
Ajou University School of Medicine
Kyungpook National University Hospital
SMG-SNU Boramae Medical Center
The Catholic University of Korea
Gangnam Severance Hospital
Severance Hospital
Eulji General Hospital
Kyung Hee University Hospital at Gangdong
Pusan National University Yangsan Hospital
Hallym University Medical Center
National Health Insurance Service Ilsan Hospital
Kangdong Sacred Heart Hospital

Investigators

  • Principal Investigator: Dong-Ryeol Ryu, Professor, Ewha Womans University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 30, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEST-IGAN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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