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Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
510 patients around the world
Available in Spain, Chile, Brazil, Argentina, Mexico, United States
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.
Alexion Pharmaceuticals, Inc.
510Patients around the world
This study is for people with
Nephropathy
Iga nephropathy
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
StudyI CAN
SponsorAlexion Pharmaceuticals, Inc.
Conditions
Iga nephropathy
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06291376
