Actively Recruiting
A Phase 3, Open-Label Study to Evaluate Ravulizumab Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy in Children Aged 2 to Under 18 With Primary Immunoglobulin A Nephropathy (IgAN)
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-03-17
24
Participants Needed
14
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, pharmacodynamics, safety, and effectiveness of ravulizumab given by intravenous infusion in children aged 2 to under 18 years with primary Immunoglobulin A Nephropathy (IgAN) or Immunoglobulin A Vasculitis Nephritis (IgAVN). This Phase 3, open-label study aims to better understand how this medication behaves in the body and its potential benefits for this condition. All participants will receive a weight-based loading dose of ravulizumab on the first day, followed by weight-based maintenance doses on Day 15 and then either every 4 or 8 weeks depending on their weight. This treatment schedule will continue through the study period, which includes up to 106 weeks for long-term evaluation. Participants will be monitored regularly through urine tests to measure protein levels, blood tests for drug concentration and complement component levels, and kidney function assessments. Researchers will also track adverse events and immune responses to the drug. The main outcome is the change in proteinuria measured by urine protein to creatinine ratio at Week 34, with ongoing safety and kidney function monitoring throughout the study.
CONDITIONS
Brief Title
Study of Ravulizumab in Pediatric Participants With Primary IgAN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 3 months prior to Screening with no planned change during Screening through Week 106.
- UPCR 63 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period.
- Estimated GFR 63 30 mL/min/1.73 m2 during Screening.
- Meningococcal infection vaccine.
- Haemophilus influenzae type b and Streptococcus pneumoniae vaccine.
- Participants receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists must be on a stable and maximum allowed or tolerated dose for 63 3 months prior to Screening with no planned change in dose through Week 34.
- Established diagnosis of primary IgAN based on kidney biopsy within 3 years prior to Screening or during the Screening Period.
You will not qualify if you...
- 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 64 6 months prior to Screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 34 weeks
Participants receive weight-based loading and maintenance doses of Ravulizumab via intravenous infusion to treat primary IgAN.
Infusions on Day 1 and Day 15, then once every 4 or 8 weeks depending on weight
Trial Site Locations
Total: 14 locations
1
Research Site
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
Research Site
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Research Site
Beijing, China, 100045
Actively Recruiting
4
Research Site
Shanghai, China, 201102
Actively Recruiting
5
Research Site
Genova, Italy, 16147
Actively Recruiting
6
Research Site
Roma, Italy, 00165
Actively Recruiting
7
Research Site
Torino, Italy, 10126
Actively Recruiting
8
Research Site
Wakayama, Japan, 641-8510
Actively Recruiting
9
Research Site
Seoul, South Korea, 03080
Actively Recruiting
10
Research Site
Barcelona, Spain, 08035
Actively Recruiting
11
Research Site
Barcelona, Spain, 8950
Actively Recruiting
12
Research Site
Seville, Spain, 41013
Actively Recruiting
13
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
14
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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