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
- Are there results?
- Not yet: the study is under way
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.
Show all 14Show fewer
- 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 (2)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
Ivkovic V, Trivioli G, Vaglio A. Management of IgA Vasculitis Nephritis Beyond Glucocorticoids. J Am Soc Nephrol. 2026 Sep 18. doi: 10.1681/ASN.0000001283. Online ahead of print. No abstract available.
PubMed 42758543Cambier 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07024563
- Acronym / sponsor ID
- D928FC00002
- Conditions
- IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis, Henoch-schonlein Purpura Nephritis, IgA Vasculitis
- Keywords
- ravulizumab, IgAN, IgAVN, pediatric, proteinuria, glomerulonephropathy, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 29 Nov 2028 (estimated)
- Study completion
- 19 Apr 2030 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ravulizumab | Experimental | Drug: RavulizumabAll 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RavulizumabParticipants will receive Ravulizumab via intravenous (IV) infusion. | Drug | Ravulizumab |
Primary outcome
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34
Time frame: Baseline, Week 34
11 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Ravulizumab
Time frame: Baseline up to Week 34
Trough Serum Concentration (Ctrough) of Ravulizumab
Time frame: Baseline up to Week 34
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration
Time frame: Baseline up to Week 34
Change from Baseline in proteinuria based on Urine Protein to Creatinine Ratio (UPCR) at Week 10
Time frame: Baseline, Week 10
Change from Baseline in Albuminuria based on Urine Albumin to Creatinine Ratio (UACR) at Week 34
Time frame: Baseline, Week 34
Number of Participants with Partial Remission
Time frame: Week 34
Annualized Total Estimated Glomerular Filtraion Rate (eGFR) over 106 weeks
Time frame: Baseline up to Week 106
Change from Baseline in eGFR
Time frame: Baseline, Weeks 50 and 106
Number of Participants with UPCR <0.5 gram of protein per gram of creatinine
Time frame: Week 34
Number of Participants With Treatment Emergent Adverse Events, Treatment Emergent Serious Adverse Events and Adverse Events of Special Interest
Time frame: Baseline up to Week 106
Number of Participants with Antidrug Antibodies to Ravulizumab and Neutralizing Antibodies
Time frame: Baseline up to Week 106
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Derived from this study: PubMed 42758543Ivkovic V, Trivioli G, Vaglio A. Management of IgA Vasculitis Nephritis Beyond Glucocorticoids. J Am Soc Nephrol. 2026 Sep 18. doi: 10.1681/ASN.0000001283. Online ahead of print. No abstract available.
- Derived from this study: PubMed 42384439Cambier 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.
- Individual participant dataSharing planned: 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.
Related trials for IgAN
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ravulizumab in people with IgAN and IgAVN, run by Alexion Pharmaceuticals, Inc. at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Italy, United States, China, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34 (time frame: Baseline, Week 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024563, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.