IgANPhase 3NCT07024563
Study of Ravulizumab in Pediatric Participants With Primary IgAN
A Phase 3 study testing Ravulizumab in people with IgAN and IgAVN, run by Alexion Pharmaceuticals, Inc. at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- IgAN, IgAVN, Immunoglobulin A Nephropathy
- What is being tested?
- Ravulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 14 Jun 2025to 19 Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 7 countries
Spain4 sites, 4 recruiting
- Not yet recruiting
Research Site
Almería, 04009
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 8950
- Recruiting
Research Site
Seville, 41013
Italy3 sites, 3 recruiting
- Recruiting
Research Site
Genova, 16147
- Recruiting
Research Site
Roma, 00165
- Recruiting
Research Site
Torino, 10126
United States2 sites, 2 recruiting
- Recruiting
Research Site
Aurora, Colorado, 80045
- Not yet recruiting
Research Site
Palo Alto, California, 94304
China2 sites, 2 recruiting
- Recruiting
Research Site
Beijing, 100045
- Recruiting
Research Site
Shanghai, 201102
Taiwan2 sites, 2 recruiting
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taoyuan, 333
About this study
Official title: 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.
- Conditions
- IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis, Henoch-schonlein Purpura Nephritis, IgA Vasculitis
- Being tested
- Ravulizumab
- Keywords
- ravulizumab, IgAN, IgAVN, pediatric, proteinuria, glomerulonephropathy, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis
- Medical subject headings
- Glomerulonephritis, IGA, IgA Vasculitis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavulizumabDrug
Participants will receive Ravulizumab via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Ravulizumab | Experimental | 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. Receives: Drug: Ravulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34
Measured: Baseline, Week 34
Secondary outcomes (11)
Maximum Observed Plasma Concentration (Cmax) of Ravulizumab
Measured: Baseline up to Week 34
Trough Serum Concentration (Ctrough) of Ravulizumab
Measured: Baseline up to Week 34
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Measured: Baseline up to Week 34
Change from Baseline in proteinuria based on Urine Protein to Creatinine Ratio (UPCR) at Week 10
Measured: Baseline, Week 10
Change from Baseline in Albuminuria based on Urine Albumin to Creatinine Ratio (UACR) at Week 34
Measured: Baseline, Week 34
Number of Participants with Partial Remission
Measured: Week 34
Annualized Total Estimated Glomerular Filtraion Rate (eGFR) over 106 weeks
Measured: Baseline up to Week 106
Change from Baseline in eGFR
Measured: Baseline, Weeks 50 and 106
Number of Participants with UPCR <0.5 gram of protein per gram of creatinine
Measured: Week 34
Number of Participants With Treatment Emergent Adverse Events, Treatment Emergent Serious Adverse Events and Adverse Events of Special Interest
Measured: Baseline up to Week 106
Number of Participants with Antidrug Antibodies to Ravulizumab and Neutralizing Antibodies
Measured: Baseline up to Week 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start14 Jun 2025
- Primary completion29 Nov 2028 (estimated)
- Study completion19 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgANStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024563
- Sponsor's protocol ID
- D928FC00002
- Other IDs
- 2024-520167-13-00, ALXN1210-IgAN-325
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Publications
Cambier A, Lachize-Neanne L, Haas M. IgA Nephropathy across the Age Spectrum: Urgent Need to Accelerate Pediatric Access to Therapeutic Innovation. Clin J Am Soc Nephrol. 2026 Jul 1. doi: 10.2215/CJN.0000001172. Online ahead of print. No abstract available.
PubMed 42384439