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ACTIVE NOT RECRUITINGPhase3

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Sponsor: Alexion Pharmaceuticals, Inc.

NCT ID: NCT06291376

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ravulizumab (drug), Placebo (drug)
How long the study runs
Study runs about 76 months (dates as stated)
About the drug or intervention
Ravulizumab — drug: Participants will receive ravulizumab via weight-based intravenous (IV) infusion. · Placebo — drug: Participants will receive placebo via weight-based IV infusion.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
584
Started
2024-03-29
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immunoglobulin a nephropathy
  • • Phase3 - 584 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immunoglobulin a nephropathy

Where?

  • • Cambridge - Research Site
  • • Doncaster - Research Site
  • • Leicester - Research Site
  • • London - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Immunoglobulin A NephropathyIgAN

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ within 6 months

What the study is looking for

  • ✓Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening...
  • ✓For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior...
  • ✓UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
  • ✓Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
  • ✓Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no...

Who cannot take part

  • ✗Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to...
  • ✗Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
  • ✗Concomitant clinically significant kidney disease other than IgAN.
  • ✗Prior use of immunosuppressive treatment within 3 months of screening.
  • ✗Uncontrolled diabetes mellitus with glycosylated red blood cell level (HbA1c) \> 8.5%.
See the full criteria
Inclusion Criteria: * Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to 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 biopsy is 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 during the Screening Period. * Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening. * Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior 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 and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose 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; 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 Treatment Period. * Splenectomy or functional asplenia. * History of Neisseria meningitidis infection. * Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

Where Is This Study? (7 UK sites)

Research Site

Cambridge CB2 0QQ, United Kingdom

Research Site

Doncaster DN2 5LT, United Kingdom

Research Site

Leicester Le5 4PW, United Kingdom

Research Site

London E1 1FR, United Kingdom

Research Site

Manchester M13 9WL, United Kingdom

Research Site

Reading RG1 5AN, United Kingdom

Research Site

Stevenage SG1 4AB, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09