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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
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

    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
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    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
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    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
    No
    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
    Email
    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
    background

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

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