Recruiting
Phase 3

Ravulizumab IV

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT07024563

Conditions

IgAN

IgAVN

Immunoglobulin A Nephropathy

Immunoglobulin A Vasculitis Associated Nephritis

Henoch-schonlein Purpura Nephritis

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Ravulizumab

Study Details

Brief 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.

Conditions

IgAN

IgAVN

Immunoglobulin A Nephropathy

Immunoglobulin A Vasculitis Associated Nephritis

Henoch-schonlein Purpura Nephritis

Study ID

NCT07024563

Start date

Jun 14, 2025

Status verified date

Jul, 2026

Completion date

Apr 19, 2030

Anticipated

Primary completion date

Nov 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ravulizumab

Participants will receive Ravulizumab via intravenous (IV) infusion.

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 and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Research Site

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-07-30.