Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

PHASE3RECRUITING

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

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Study details:

The I CAN study will enroll approximately 450 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening, Participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR.

In addition, approximately 20 participants with eGFR 20-29 mL/min/1. 73m2 will be enrolled in an Exploratory Cohort and will receive open label weight-based IV infusion of ravulizumab. After Week 106, all participants have the option to enter a post-study access period and receive open-label ravulizumab.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period.
  • UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during Screening.
  • Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
  • Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
  • Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥ 5 red blood cells (RBCs)/high power field microscopy on urine sediment during or within 3 months of Screening.
  • Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
  • Participants who are on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change through Week 106.
  • Exclusion criteria

  • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
  • Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease).
  • Concomitant clinically significant renal disease other than IgAN.
  • Prior use of immunosuppressive treatment for IgAN within 6 months of screening.
  • Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.
  • Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic immunosuppressive therapy at Screening.
  • History of kidney transplant or planned kidney transplant during the Treatment Period.
  • Splenectomy or functional asplenia.
  • History of Neisseria meningitidis infection.
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-03-29

    Primary completion: 2026-02-23

    Study completion finish: 2029-10-25

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06291376

    Intervention or treatment

    DRUG: Ravulizumab

    DRUG: Placebo

    Conditions

    • Immunoglobulin A Nephropathy
    • IgAN
    Image related to Immunoglobulin A Nephropathy
    • Condition: Immunoglobulin A Nephropathy, IgAN

    • DRUG: Ravulizumab and other drugs

    • Camperdown, Not Specified, Australia and more

    • Sponsor: Alexion Pharmaceuticals, Inc.

    Find a site

    Closest Location:

    Research Site

    Research sites nearby

    Select from list below to view details:

    • Research Site

      Camperdown, Not Specified, Australia

    • Research Site

      Canberra, Not Specified, Australia

    • Research Site

      Clayton, Not Specified, Australia

    • Research Site

      Concord, Not Specified, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Ravulizumab IV q8w
    • Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
    • Participants in the exploratory group will receive open-label weight based loading dose on Day 1 followed by open label weight based maintenance dose on Day 15 and q8weeks after.
    DRUG: Ravulizumab
    • Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
    PLACEBO_COMPARATOR: Placebo IV q8w
    • Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.
    DRUG: Placebo
    • Participants will receive placebo via weight-based IV infusion.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34Evaluated at interim analysis onlyBaseline, Week 34
    Glomerular Filtration Rate (eGFR) Over 106 WeeksEvaluated at final analysis onlyUp to Week 106

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106Evaluated at interim and final analysisBaseline, Weeks 10, 26, 34, 50, and 106
    Change From Baseline in eGFR at Weeks 34, 50, and 106Evaluated at interim and final analysisBaseline, Weeks 34, 50, and 106
    Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106Evaluated at interim and final analysisBaseline, Weeks 10, 26, 34,50, and 106
    Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106Evaluated at interim and final analysisBaseline, Weeks 10, 26, 34, 50, and 106
    Number of Participants With Partial Remission at Weeks 34, 50, and 106Evaluated at interim and final analysisWeeks 34, 50, and 106
    Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106Evaluated at interim and final analysisBaseline, Weeks 34, 50, and 106
    Number of Participants With Composite Kidney Failure EndpointComposite kidney failure endpoint is defined as reaching at least 1 of the following: Sustained ≥ 30% decline in eGFR relative to baseline; or Sustained eGFR \< 15 milliliter (mL)/minute (min)/1.73 square meter (m\^2); or Maintenance dialysis; or Receipt of kidney transplant; or Death from kidney failure. Evaluated at the final analysis onlyBaseline up to Week 106
    Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106Evaluated at the final analysis onlyBaseline, Weeks 34 and 106
    Number of Participants With Kidney Hierarchical Composite EndpointThe kidney hierarchical composite endpoint is defined as the most severe outcome of a participant according to the following severity of outcomes: death from kidney failure, kidney transplant, maintenance dialysis, sustained eGFR \< 15 mL/min/1.73 m\^2, sustained eGFR decline from baseline ≥ 30%, or eGFR slope. Evaluated at the final analysis onlyBaseline up to Week 106

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    References

    Clinical Trials Gov: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

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