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Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

Primary Purpose

Glomerulonephritis, IGA

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Prednisolone
Prednisolone plus Cyclophosphamide
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis, IGA

Eligibility Criteria

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

Inclusion Criteria:

  • Biopsy-proven IgA nephropathy;
  • Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
  • Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.

Exclusion Criteria:

  • Indication or contraindication for immunosuppressive therapy with corticosteroids
  • Use of corticosteroids and other immunosuppressive drugs within the last 1 year
  • Current unstable kidney function for other reasons
  • Under 18 years old
  • Patients with secondary IgAN
  • Patients who are unlikely to comply with the study protocol in the view of the treating physician

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    CS

    CS+CTX

    Arm Description

    low-dose corticosteroids monotherapy

    low-dose corticosteroids combined with cyclophosphamide

    Outcomes

    Primary Outcome Measures

    Combined event
    40% decrease in eGFR, ESRD or death due to kidney disease

    Secondary Outcome Measures

    Proteinuria remission at 6, 12 months and total follow-up period
    Proteinuria remission
    Hematuria remission at 6, 12 months and total follow-up period
    Hematuria remission
    The composite of 30% decrease in eGFR, ESRD and all cause death
    The composite of 40% decrease in eGFR, ESRD and all cause death
    The composite of 50% decrease in eGFR, ESRD and all cause death
    Annual eGFR decline rate
    30% decrease in eGFR
    40% decrease in eGFR
    50% decrease in eGFR
    ESRD
    All cause death

    Full Information

    First Posted
    August 18, 2022
    Last Updated
    August 19, 2022
    Sponsor
    Air Force Military Medical University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05510323
    Brief Title
    Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
    Official Title
    Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    August 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Air Force Military Medical University, China

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    208 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CS
    Arm Type
    Active Comparator
    Arm Description
    low-dose corticosteroids monotherapy
    Arm Title
    CS+CTX
    Arm Type
    Active Comparator
    Arm Description
    low-dose corticosteroids combined with cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone
    Intervention Description
    RAS blockade as much as tolerated or allowed
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone plus Cyclophosphamide
    Intervention Description
    RAS blockade as much as tolerated or allowed
    Primary Outcome Measure Information:
    Title
    Combined event
    Description
    40% decrease in eGFR, ESRD or death due to kidney disease
    Time Frame
    up to 6 years
    Secondary Outcome Measure Information:
    Title
    Proteinuria remission at 6, 12 months and total follow-up period
    Description
    Proteinuria remission
    Time Frame
    up to 6 years
    Title
    Hematuria remission at 6, 12 months and total follow-up period
    Description
    Hematuria remission
    Time Frame
    up to 6 years
    Title
    The composite of 30% decrease in eGFR, ESRD and all cause death
    Time Frame
    up to 6 years
    Title
    The composite of 40% decrease in eGFR, ESRD and all cause death
    Time Frame
    up to 6 years
    Title
    The composite of 50% decrease in eGFR, ESRD and all cause death
    Time Frame
    up to 6 years
    Title
    Annual eGFR decline rate
    Time Frame
    up to 6 years
    Title
    30% decrease in eGFR
    Time Frame
    up to 6 years
    Title
    40% decrease in eGFR
    Time Frame
    up to 6 years
    Title
    50% decrease in eGFR
    Time Frame
    up to 6 years
    Title
    ESRD
    Time Frame
    up to 6 years
    Title
    All cause death
    Time Frame
    up to 6 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Biopsy-proven IgA nephropathy; Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade; Estimated glomerular filtration rate 15-60 ml/min/1.73/m2. Exclusion Criteria: Indication or contraindication for immunosuppressive therapy with corticosteroids Use of corticosteroids and other immunosuppressive drugs within the last 1 year Current unstable kidney function for other reasons Under 18 years old Patients with secondary IgAN Patients who are unlikely to comply with the study protocol in the view of the treating physician

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

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