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NCT07024563PHASE3Recruiting

Study of Ravulizumab in Pediatric Participants With Primary IgAN

Alexion Pharmaceuticals, Inc.

Start Date

6/14/2025

Completion Date

4/19/2030

Summary

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.

Eligibility Criteria

Age Range: 2 years to 18 years

Inclusion Criteria: * Participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent. * Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106. * UPCR ≥ 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period * Estimated GFR ≥ 30 mL/min/1.73 m2 during Screening * Meningococcal infection vaccine * Haemophilus influenzae type b and Streptococcus pneumoniae vaccine * Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists 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 34. * Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period Exclusion Criteria: * Diagnosis of rapidly progressive glomerulonephritis * Secondary forms of IgAN not in the context of primary IgAN or IgAV * Concomitant clinically significant renal disease other than IgAN or IgAVN * Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months. * Uncontrolled diabetes mellitus with HbA1c \> 8.5% * History of kidney transplant or planned kidney transplant during the Primary Evaluation Period. * History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant * Splenectomy or functional asplenia * Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening. * Hemolytic uremic syndrome diagnosed any time prior to Screening. * Planned urological surgery expected to influence kidney function within the study time frame. * Congenital immunodeficiency * Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment * Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening

Interventions

DRUG

Ravulizumab

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Conditions

IgANIgAVNImmunoglobulin A NephropathyImmunoglobulin A Vasculitis Associated NephritisHenoch-schonlein Purpura NephritisIgA Vasculitis

Locations

Research Site

Palo Alto, California 94304

United States

Research Site

Aurora, Colorado 80045

United States

Research Site

Beijing, 100045

China

Research Site

Shanghai, 201102

China

Research Site

Genova, 16147

Italy

Research Site

Roma, 00165

Italy

Research Site

Torino, 10126

Italy

Research Site

Wakayama, 641-8510

Japan

Research Site

Seoul, 03080

South Korea

Research Site

Almería, 04009

Spain

Research Site

Barcelona, 08035

Spain

Research Site

Barcelona, 8950

Spain

Research Site

Seville, 41013

Spain

Research Site

Taipei, 10002

Taiwan

Research Site

Taoyuan, 333

Taiwan