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

NCT ID: NCT03357653

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glomerulonephritis, Immunoglobulin A (IgA)

Keywords

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proteinuria progression early immunoglobulin A (IgA) nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Losartan group

Losartan 50 mg daily

Group Type EXPERIMENTAL

Losartan group

Intervention Type DRUG

Losartan 50 mg daily

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DRUG

Placebo 1 pill daily

Interventions

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Losartan group

Losartan 50 mg daily

Intervention Type DRUG

Placebo group

Placebo 1 pill daily

Intervention Type DRUG

Other Intervention Names

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Losartan Placebo

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Eulji General Hospital

OTHER

Sponsor Role collaborator

National Health Insurance Service Ilsan Hospital

OTHER

Sponsor Role collaborator

Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Chonbuk National University Hospital

OTHER

Sponsor Role collaborator

Kangdong Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role collaborator

Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong-Ryeol Ryu, Professor

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University

Central Contacts

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Dong-Ryeol Ryu, Professor

Role: CONTACT

Phone: 82-2-2650-2507

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23331443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26874511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9631840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11007671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11331053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17596724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24946688 (View on PubMed)

Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Reference Type DERIVED
PMID: 38299639 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BEST-IGAN-001

Identifier Type: -

Identifier Source: org_study_id