NCT07024563 · Alexion Pharmaceuticals, Inc.
Study of Ravulizumab in Pediatric Participants With Primary IgAN
What this study is about
The primary objectives of this study are to characterize ravulizumab how the drug moves through the body (PK) and how the drug affects the body (PD), and to evaluate safety and effectiveness following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 RASI (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 criteria
- 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.
- 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
Where
- Palo Alto, California
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations