Skip to content
Bored Studies
RecruitingPhase 3

Study of Ravulizumab in Pediatric Participants With Primary IgAN

Alexion Pharmaceuticals, Inc. · NCT07024563

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–18 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
36
US sites recruiting
1
Study start
June 14, 2025
Record last updated
July 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ravulizumab

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Alexion Pharmaceuticals, Inc. (Sponsor) · 1-855-752-2356 · clinicaltrials@alexion.com
Study of Ravulizumab in Pediatric Participants With Primary IgAN (NCT07024563) | Bored Studies