Actively Recruiting
Study of Ravulizumab in Pediatric Participants With Primary IgAN
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-03-17
24
Participants Needed
14
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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
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 6 months prior to Screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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)
CONTACT
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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