RECRUITING

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

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Conditions

Immunoglobulin A NephropathyIgANproteinuriaglomerulonephropathychronic kidney diseaseCKD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-03-29
Study Completion:2030-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06291376

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  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.
  3. * UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
  4. * Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
  5. * 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.
  6. * 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.
  1. * Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
  2. * Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
  3. * Concomitant clinically significant renal disease other than IgAN.
  4. * Prior use of immunosuppressive treatment within 3 months of screening.
  5. * Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.
  6. * Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
  7. * History of kidney transplant or planned kidney transplant during the Treatment Period.
  8. * Splenectomy or functional asplenia.
  9. * History of Neisseria meningitidis infection.
  10. * Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Research Site
Alabaster, Alabama, 35007
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
Loma Linda, California, 92354
United States
Research Site
Los Angeles, California, 90022
United States
Research Site
Los Angeles, California, 90027
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Orange, California, 92868
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Stanford, California, 94305
United States
Research Site
Torrance, California, 90502
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Bay Pines, Florida, 33744
United States
Research Site
Miami, Florida, 33136
United States
Research Site
Orlando, Florida, 32806
United States
Research Site
Acworth, Georgia, 30101
United States
Research Site
Lawrenceville, Georgia, 30046
United States
Research Site
Iowa City, Iowa, 52242
United States
Research Site
New Orleans, Louisiana, 70121
United States
Research Site
Shreveport, Louisiana, 71103
United States
Research Site
Augusta, Maine, 04330
United States
Research Site
Boston, Massachusetts, 02111
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Pontiac, Michigan, 48341
United States
Research Site
Minneapolis, Minnesota, 55435
United States
Research Site
Minneapolis, Minnesota, 55455
United States
Research Site
Saint Peters, Missouri, 63376
United States
Research Site
North Las Vegas, Nevada, 89086
United States
Research Site
Albany, New York, 12208
United States
Research Site
Bronx, New York, 10468
United States
Research Site
East Setauket, New York, 11733
United States
Research Site
New York, New York, 10016
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Charleston, South Carolina, 29425
United States
Research Site
Knoxville, Tennessee, 37920
United States
Research Site
Arlington, Texas, 76002
United States
Research Site
Houston, Texas, 77054
United States
Research Site
Shenandoah, Texas, 77384
United States
Research Site
Charlottesville, Virginia, 22903
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-29
Study Completion Date2030-12-23

Study Record Updates

Study Start Date2024-03-29
Study Completion Date2030-12-23

Terms related to this study

Keywords Provided by Researchers

  • Immunoglobulin A nephropathy
  • IgAN
  • proteinuria
  • glomerulonephropathy
  • chronic kidney disease
  • CKD

Additional Relevant MeSH Terms

  • Immunoglobulin A Nephropathy
  • IgAN