Refer a Patient

Do you have a patient with immunoglobulin A nephropathy (IgAN) who may be interested in the I CAN Study?

The I CAN Study is enrolling approximately 470 adult participants who have immunoglobulin A nephropathy (IgAN).

The I CAN Study is a phase 3, double-blind, randomized, placebo-controlled study. The total duration of participation is approximately 4 years. The study consists of a screening period, a study treatment period, and ravulizumab access period.

Participants will be randomized in a 1:1 ratio to receive either ravulizumab or the placebo. The study treatment will be administered as an intravenous (IV) infusion once every 8 weeks.

Primary Objective

The primary objective of this study is to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow disease progression in adult participants with IgAN. Patients with active inflammation suggested by high proteinuria may receive additional clinical benefit from the potent anti-inflammatory effects of anti-C5.

Eligibility Criteria

Key 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 as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI)
  • 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. Kidney biopsy report must demonstrate < 75% each of interstitial fibrosis, tubular atrophy, and glomerular sclerosis.
  • 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
  • NOTE: Patients with UPCR ≥ 0.75 g/g are eligible to be enrolled. However, please note that:
    • UPCR ≥ 1.5 g/g represents patients with the greatest risk for disease progression and therefore the greatest unmet need, and
    • These patients may have greater renal inflammation, which may be rapidly addressed by ravulizumab’s MOA, which enables immediate, complete, and sustained complement inhibition
  • Adherence to and compliance with 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 with intolerance to RASi medications may be included.

Key Exclusion Criteria

  • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to screening
  • Secondary IgAN (e.g., due to systemic lupus erythematosus [SLE], cirrhosis, or celiac disease)
  • Concomitant clinically significant renal disease other than IgAN
  • Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
  • History of kidney transplant or planned kidney transplant during the treatment period
  • Body mass index ≥ 38 kg/m2

Additional eligibility criteria, according to approved protocol, apply.

I CAN Study Research Sites

If you have a patient who may be interested in participating, and you think may qualify, refer your patient to this study website to take the prescreening questionnaire to determine eligibility.