Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

About

Brief Summary

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.
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.

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).
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.