Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Last updated: February 18, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Glomerulonephritis

Treatment

Ravulizumab

Placebo

Clinical Study ID

NCT06291376
D928FC00001
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of IgAN diagnosis established on kidney biopsy obtained any time priorto or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m^2.

  • For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsyis required within 6 months prior to Screening or during the Screening Period.

  • UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine duringthe Screening Period.

  • Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.

  • Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 monthsprior to Screening with no planned change during Screening through Week 106.

  • Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable andmaximum allowed or tolerated dose for ≥ 3 months prior to Screening with no plannedchange in dose through Week 106.

Exclusion

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 celiacdisease; IgAV-N may be eligible).

  • Concomitant clinically significant renal disease other than IgAN.

  • Prior use of immunosuppressive treatment within 3 months of screening.

  • Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.

  • Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.

  • History of kidney transplant or planned kidney transplant during the TreatmentPeriod.

  • Splenectomy or functional asplenia.

  • History of Neisseria meningitidis infection.

  • Active systemic bacterial, viral, or fungal infection within 14 days prior torandomization.

Study Design

Total Participants: 510
Treatment Group(s): 2
Primary Treatment: Ravulizumab
Phase: 3
Study Start date:
March 29, 2024
Estimated Completion Date:
December 23, 2030

Study Description

The I CAN study will enroll approximately 510 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. Approximately 450 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 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

Connect with a study center

  • Research Site

    Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Research Site

    Ciudad Autonoma Bs As, C1015ABO
    Argentina

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    Cordoba, X5016KET
    Argentina

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    Córdoba, X5016LIG
    Argentina

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    Florencio Varela, 1888
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    La Plata, B1902COS
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    Rosario, 2000
    Argentina

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    San Luis, D5700
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    Camperdown, 2050
    Australia

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    Canberra, 2605
    Australia

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    Clayton, 3168
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    Concord, 2139
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    Herston, 4029
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    Liverpool, 2170
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    Parkville, 3050
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    Perth, 6000
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    Southport, 4222
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    St Albans, 3021
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    Liège, 4000
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    Roeselare, 8800
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    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • Research Site

    North Las Vegas, Nevada 89086
    United States

    Active - Recruiting

  • Research Site

    Albany, New York 12208
    United States

    Active - Recruiting

  • Research Site

    Bronx, New York 10468
    United States

    Active - Recruiting

  • Research Site

    East Setauket, New York 11733
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Research Site

    Arlington, Texas 76002
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Research Site

    Shenandoah, Texas 77384
    United States

    Active - Recruiting

  • Research Site

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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