Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Immunoglobulin A Nephropathy, IgAN

In brief

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.

Key facts

Study ID

NCT06291376

Run by

Alexion Pharmaceuticals, Inc.

People needed

579

Starts

2024-03-29

Expected to finish

2030-07-19

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Research Site — Phoenix, Arizona, 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 Bernardino, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Stanford, California, United States
• Research Site — Torrance, California, United States
• Research Site — Valencia, California, United States
• Research Site — Bay Pines, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Acworth, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.