Who is eligible for clinical trial NCT07024563?

Participants must meet the protocol's inclusion criteria for IgAN. The stated age range is 2 Years to 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07024563 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-29

Study of Ravulizumab in Pediatric Participants With Primary IgAN (NCT07024563)

A Phase 3, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to < 18 Years of Age) With Primary Immunoglobulin A Nephropathy (IgAN)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Alexion Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (15 items).

Location: Research Site — Palo Alto, California

Age range: 2 Years to 18 Years

🧪 Interventions in This Study

Ravulizumab (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📞 Contact the Study Coordinator

Phone: (855) 752-2356

Email: clinicaltrials@alexion.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in IgAN

Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease — Doral, Florida

Explore by condition: All IgAN clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗