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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
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
