Study of Ravulizumab in Pediatric Participants With Primary IgAN

Part of paid clinical trials in Palo Alto, California.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT07024563
Phase
PHASE3
Status
Recruiting
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Conditions

  • Henoch-schonlein Purpura Nephritis
  • IgA Vasculitis
  • IgAN
  • IgAVN
  • Immunoglobulin A Nephropathy
  • Immunoglobulin A Vasculitis Associated Nephritis

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — DRUG
    Participants will receive Ravulizumab via intravenous (IV) infusion.

Study Details

The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.

Key Dates

Start date
Jun 14, 2025
Status verified
Mar 2026
Primary completion
Jul 12, 2028
Completion
Nov 27, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ravulizumab
    All participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and either once every 8 weeks (q8w) thereafter or once every 4 weeks (q4w) depending on weight.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SitePalo AltoCalifornia94304-
Research SiteAuroraColorado80045-

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By research site
Research Site· Palo Alto, CAResearch Site· Aurora, CO

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