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Study of Ravulizumab in Pediatric Participants With Primary IgAN

NCT ID: NCT07024563

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-14

Study Completion Date

2029-11-27

Brief Summary

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The primary objective of this study is to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population.

Detailed Description

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Conditions

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

Keywords

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ravulizumab IgAN IgAVN pediatric proteinuria glomerulonephropathy Immunoglobulin A Nephropathy Immunoglobulin A Vasculitis Associated Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ravulizumab

Intervention Type DRUG

Participants will receive Ravulizumab via intravenous (IV) infusion.

Interventions

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Ravulizumab

Participants will receive Ravulizumab via intravenous (IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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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 RASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
* UPCR ≥ 0.5 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

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
* 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 ≤ 6 months prior to Screening
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Aurora, Colorado, United States

Site Status RECRUITING

Research Site

Beijing, , China

Site Status RECRUITING

Research Site

Shanghai, , China

Site Status RECRUITING

Research Site

Genova, , Italy

Site Status RECRUITING

Research Site

Roma, , Italy

Site Status RECRUITING

Research Site

Torino, , Italy

Site Status RECRUITING

Research Site

Wakayama, , Japan

Site Status NOT_YET_RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Seville, , Spain

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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United States China Italy Japan South Korea Spain Taiwan

Central Contacts

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Alexion Pharmaceuticals, Inc. (Sponsor)

Role: CONTACT

Phone: 1-855-752-2356

Email: [email protected]

Other Identifiers

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2024-520167-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

D928FC00002

Identifier Type: -

Identifier Source: org_study_id