Loading clinical trials...

RECRUITINGPHASE3

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)

NCT06291376•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 RASI (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.

Locations (267)

Research Site

Alabaster, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Loma Linda, California, United States

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Orange, California, United States

Research Site

San Diego, California, United States

Research Site

San Francisco, California, United States

Research Site

Stanford, California, United States

Key Dates

Start Date

March 29, 2024

Primary Completion Date

January 5, 2026

Completion Date

July 19, 2030

Last Updated

March 19, 2026

Enrollment

510

ESTIMATED participants

Conditions

Immunoglobulin A NephropathyIgAN

Interventions

Ravulizumab

DRUG

Placebo

DRUG

Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356 clinicaltrials@alexion.com

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

NCT00001595

PanhypopituitarismGigantism/Acromegaly+2 more

View study

RECRUITINGPHASE2

Hematopoietic Stem Cell Transplantation (HSCT) for Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD)

NCT07284641

Common Variable Immunodeficiency (CVID)Primary Immune Regulatory Disorder+13 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Inclusion Criteria

Exclusion Criteria

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

Hematopoietic Stem Cell Transplantation (HSCT) for Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD)

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

A Study of Zigakibart in Adults With IgA Nephropathy