NCT07024563RecruitingPhase 3
Study of Ravulizumab in Pediatric Participants With Primary IgAN
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)
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- 14 Jun 2025
- Primary completion date
- 29 Nov 2028
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Diseases
- IgA nephropathy
- NCT number
- NCT07024563
- EU CT number
- 2024-520167-13-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 36
- From 14 Jun 2025 to the primary completion date, 29 Nov 2028
- 15 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant clinically significant renal disease other than IgAN or IgAVN
- Hemolytic uremic syndrome diagnosed any time prior to Screening.
- Planned urological surgery expected to influence kidney function within the study time frame.
- 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
Other illness
- 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
Lab values
- Uncontrolled diabetes mellitus with HbA1c \> 8.5%
- Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening.
Other
- Diagnosis of rapidly progressive glomerulonephritis
- Secondary forms of IgAN not in the context of primary IgAN or IgAV
- Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months.
- Splenectomy or functional asplenia
- Congenital immunodeficiency
Who the study is looking for
- 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
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Wakayama | Japan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Palo Alto | United States | Not yet recruiting |
Related publications
- Management of IgA Vasculitis Nephritis Beyond Glucocorticoids.J Am Soc Nephrol · 2026 · PMID 42758543
- IgA Nephropathy across the Age Spectrum: Urgent Need to Accelerate Pediatric Access to Therapeutic Innovation.Clin J Am Soc Nephrol · 2026 · PMID 42384439
This page is information, not medical advice. Discuss any trial with your doctor.