A Phase 3 interventional study of Ravulizumab in IgAN, IgAVN and Immunoglobulin A Nephropathy, sponsored by Alexion Pharmaceuticals, Inc.. Recruiting at 15 sites in 7 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 36 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.
First submitted after Alexion Pharmaceuticals, Inc. became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ravulizumab
Participants will receive Ravulizumab via intravenous (IV) infusion.
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34
Time frame: Baseline, Week 34
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
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Ravulizumab
Alexion Pharmaceuticals, Inc. →