Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Part of paid clinical trials in Alabaster, Alabama.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT06291376
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • IgAN
  • Immunoglobulin A Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — DRUG
    Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
  • Placebo — DRUG
    Participants will receive placebo via weight-based IV infusion.

Study Details

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 Dates

Start date
Mar 29, 2024
Status verified
Apr 2026
Primary completion
Jan 5, 2026
Completion
Jul 19, 2030

Study Design

Enrollment
510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ravulizumab IV q8w
    Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
  • Placebo Comparator: Placebo IV q8w
    Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.

Primary Outcome Measure

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 [ Time Frame: Baseline, Week 34 ]

Central Contacts

Locations (46)

FacilityCityStateZIPSite coordinators
Research SiteAlabasterAlabama35007-
Research SitePhoenixArizona85054-
Research SiteLoma LindaCalifornia92354-
Research SiteLos AngelesCalifornia90022-
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90095-
Research SiteOrangeCalifornia92868-
Research SiteSan DiegoCalifornia92120-
Research SiteSan FranciscoCalifornia94143-
Research SiteStanfordCalifornia94305-
Research SiteTorranceCalifornia90502-
Research SiteValenciaCalifornia91355-
Research SiteAuroraColorado80045-
Research SiteBay PinesFlorida33744-
Research SiteMiamiFlorida33136-
Research SiteOrlandoFlorida32806-
Research SiteAcworthGeorgia30101-
Research SiteAtlantaGeorgia30322-
Research SiteLawrencevilleGeorgia30046-
Research SiteIowa CityIowa52242-
Research SiteNew OrleansLouisiana70121-
Research SiteShreveportLouisiana71103-
Research SiteAugustaMaine04330-
Research SiteBostonMassachusetts02111-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteWorcesterMassachusetts01655-
Research SiteMinneapolisMinnesota55435-
Research SiteMinneapolisMinnesota55455-
Research SiteKansas CityMissouri64111-
Research SiteNorth Las VegasNevada89086-
Research SiteAlbanyNew York12208-
Research SiteEast SetauketNew York11733-
Research SiteNew YorkNew York10016-
Research SiteThe BronxNew York10468-
Research SiteColumbusOhio43210-
Research SiteCharlestonSouth Carolina29425-
Research SiteKnoxvilleTennessee37920-
Research SiteArlingtonTexas76002-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77054-
Research SiteSan AntonioTexas78229-
Research SiteShenandoahTexas77384-
Research SiteTempleTexas76508-
Research SiteCharlottesvilleVirginia22908-
Research SiteMilwaukeeWisconsin53226-

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