Study of Ravulizumab in Pediatric Participants With Primary IgAN

Launched by ALEXION PHARMACEUTICALS, INC. · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called ravulizumab to see how it works and how the body handles it in children and teenagers with a kidney condition called primary IgA nephropathy (IgAN) or related diseases. These conditions affect the kidneys and can cause problems with how well they filter waste from the blood. The goal is to learn from how ravulizumab helps adults and see if it could be safe and effective for younger patients.

Children and teens from 2 up to just under 18 years old who have stable kidney function and are already on certain kidney medications may be eligible to join. Participants need to have a specific level of protein in their urine, which shows ongoing kidney issues. They also must have received vaccines to protect against certain infections before joining. If accepted, they will receive ravulizumab through an IV (a drip into the vein), and doctors will closely monitor how the medicine works in their bodies over time. It’s important to know that this study is not yet recruiting participants, and certain health conditions or treatments may prevent someone from joining.

Gender

ALL

Eligibility criteria

• 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 ≥ 0.5 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
• 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
• • 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 ≤ 6 months prior to Screening