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

Primary Purpose

Glomerulonephritis, Immunoglobulin A (IgA)

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Losartan group

Placebo group

About this trial

This is an interventional treatment trial for Glomerulonephritis, Immunoglobulin A (IgA) focused on measuring proteinuria, progression, early immunoglobulin A (IgA) nephropathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain
Age >= 19 years
Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1
Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1
People who voluntarily agreed to participate
People who are compliant

Exclusion Criteria:

Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs
Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes
Previous immunosuppressive drugs use to treat IgAN
Secondary IgAN
Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others)
hypersensitivity to RASI
Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease
Pregnancy
symptomatic orthostatic hypotension
People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit
Inappropriate people ascertained by investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Losartan group

Placebo group

Arm Description

Losartan 50 mg daily

Placebo 1 pill daily which has same size, color and taste with losartan

Outcomes

Primary Outcome Measures

Significant proteinuria rate

Random urine protein-to-creatinine ratio >= 1g/g creatinine

Secondary Outcome Measures

Proteinuria remission rate

Random urine protein-to-creatinine ratio < 0.20 g/g creatinine

Impaired kidney function rate

estimated glomerular filtration rate decline >= 40% from the baseline value

Hypertension development rate

Systolic blood pressure >= 140 or diastolic blood pressure >= 90

Full Information

NCT ID

NCT03357653

First Posted

November 15, 2017

Last Updated

November 28, 2017

Sponsor

Ewha Womans University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03357653

Brief Title

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

Acronym

BEST-IgAN-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 30, 2018 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ewha Womans University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glomerulonephritis, Immunoglobulin A (IgA)

Keywords

proteinuria, progression, early immunoglobulin A (IgA) nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Losartan group

Arm Type

Experimental

Arm Description

Losartan 50 mg daily

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo 1 pill daily which has same size, color and taste with losartan

Intervention Type

Drug

Intervention Name(s)

Losartan group

Other Intervention Name(s)

Losartan

Intervention Description

Losartan 50 mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo group

Other Intervention Name(s)

Placebo

Intervention Description

Placebo 1 pill daily

Primary Outcome Measure Information:

Title

Significant proteinuria rate

Description

Random urine protein-to-creatinine ratio >= 1g/g creatinine

Time Frame

144 weeks after study started

Secondary Outcome Measure Information:

Title

Proteinuria remission rate

Description

Random urine protein-to-creatinine ratio < 0.20 g/g creatinine

Time Frame

48 weeks, 96 weeks, and 144 weeks after study started

Title

Impaired kidney function rate

Description

estimated glomerular filtration rate decline >= 40% from the baseline value

Time Frame

48 weeks, 96 weeks, and 144 weeks after study started

Title

Hypertension development rate

Description

Systolic blood pressure >= 140 or diastolic blood pressure >= 90

Time Frame

48 weeks, 96 weeks, and 144 weeks after study started

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy-proven IgAN: dominant or co-dominant deposits of mesangial IgA in immunofluorescence stain Age >= 19 years Random urine protein-to-creatinine ratio 0.3 g/g creatinine to 1.0 g/g creatinine at visit 1 Estimated glomerular filtration rate >= 60 mL/min/1.73m2 at visit 1 People who voluntarily agreed to participate People who are compliant Exclusion Criteria: Prevalent Hypertension: systolic blood pressure >=140 mmHg and >=90 mmHg, previous physician diagnosis of hypertension, or taking anti-hypertensive drugs Prevalent Diabetes: fasting glucose >= 126 mg/dL, HbA1c >= 6.5%, taking insulin or anti-diabetic drugs, or previous physician diagnosis of diabetes Previous immunosuppressive drugs use to treat IgAN Secondary IgAN Renin-angiotensin-aldosterone inhibitors (RASI) dependent patients (congestive heart failure, ischemic heart disease, and others) hypersensitivity to RASI Other chronic diseases: malignancy within 5 years, significant liver and gastrointestinal disease and other autoimmune disease Pregnancy symptomatic orthostatic hypotension People who already participated in other interventional studies or taking interventional drugs within 3 month of screening visit Inappropriate people ascertained by investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong-Ryeol Ryu, Professor

Phone

82-2-2650-2507

drryu@ewha.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong-Ryeol Ryu, Professor

Organizational Affiliation

Ewha Womans University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23331443

Citation

Li PK, Kwan BC, Chow KM, Leung CB, Szeto CC. Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. Am J Med. 2013 Feb;126(2):162-8. doi: 10.1016/j.amjmed.2012.06.028.

Results Reference

background

PubMed Identifier

26874511

Citation

Jo YI, Na HY, Moon JY, Han SW, Yang DH, Lee SH, Park HC, Choi HY, Lim SD, Kie JH, Lee YK, Shin SK. Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial. Korean J Intern Med. 2016 Mar;31(2):335-43. doi: 10.3904/kjim.2014.266. Epub 2016 Feb 15.

Results Reference

background

PubMed Identifier

9631840

Citation

Nieuwhof C, Kruytzer M, Frederiks P, van Breda Vriesman PJ. Chronicity index and mesangial IgG deposition are risk factors for hypertension and renal failure in early IgA nephropathy. Am J Kidney Dis. 1998 Jun;31(6):962-70. doi: 10.1053/ajkd.1998.v31.pm9631840.

Results Reference

background

PubMed Identifier

11007671

Citation

Lai FM, Szeto CC, Choi PC, Li PK, Chan AW, Tang NL, Lui SF, Wang AY, To KF. Characterization of early IgA nephropathy. Am J Kidney Dis. 2000 Oct;36(4):703-8. doi: 10.1053/ajkd.2000.17614.

Results Reference

background

PubMed Identifier

11331053

Citation

Szeto CC, Lai FM, To KF, Wong TY, Chow KM, Choi PC, Lui SF, Li PK. The natural history of immunoglobulin a nephropathy among patients with hematuria and minimal proteinuria. Am J Med. 2001 Apr 15;110(6):434-7. doi: 10.1016/s0002-9343(01)00659-3.

Results Reference

background

PubMed Identifier

17596724

Citation

Shen P, He L, Li Y, Wang Y, Chan M. Natural history and prognostic factors of IgA nephropathy presented with isolated microscopic hematuria in Chinese patients. Nephron Clin Pract. 2007;106(4):c157-61. doi: 10.1159/000104426. Epub 2007 Jun 26.

Results Reference

background

PubMed Identifier

24946688

Citation

Lee H, Hwang JH, Paik JH, Ryu HJ, Kim DK, Chin HJ, Oh YK, Joo KW, Lim CS, Kim YS, Lee JP. Long-term prognosis of clinically early IgA nephropathy is not always favorable. BMC Nephrol. 2014 Jun 19;15:94. doi: 10.1186/1471-2369-15-94.

Results Reference

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

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