Tests ravulizumab in children with IgA nephropathy kidney disease
Tests ravulizumab, given through a vein, in children with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Study of Ravulizumab in Pediatric Participants With Primary IgAN
Key facts
- Where
- Genoa, Rome, and Turin, ItalySee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 18 years old?
Source: NCT07024563, who can take part
Where in Italy
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Trial code
- NCT07024563EU 2024-520167-13-00
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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; 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; 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.