Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Description

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.

Conditions

Immunoglobulin A Nephropathy, IgAN

Study Overview

Study Details

Study overview

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.

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)

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Condition
Immunoglobulin A Nephropathy
Intervention / Treatment

-

Contacts and Locations

Alabaster

Research Site, Alabaster, Alabama, United States, 35007

Phoenix

Research Site, Phoenix, Arizona, United States, 85054

Loma Linda

Research Site, Loma Linda, California, United States, 92354

Los Angeles

Research Site, Los Angeles, California, United States, 90022

Los Angeles

Research Site, Los Angeles, California, United States, 90027

Los Angeles

Research Site, Los Angeles, California, United States, 90095

Orange

Research Site, Orange, California, United States, 92868

San Francisco

Research Site, San Francisco, California, United States, 94143

Stanford

Research Site, Stanford, California, United States, 94305

Torrance

Research Site, Torrance, California, United States, 90502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Study Record Dates

2030-12-23