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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive Ravulizumab via intravenous (IV) infusion.
Research Site
Aurora, Colorado, United States
RECRUITINGResearch Site
Beijing, China
RECRUITINGResearch Site
Shanghai, China
RECRUITINGResearch Site
Genova, Italy
RECRUITINGResearch Site
Roma, Italy
RECRUITINGResearch Site
Torino, Italy
RECRUITINGResearch Site
Wakayama, Japan
NOT_YET_RECRUITINGResearch Site
Seoul, South Korea
RECRUITINGResearch Site
Barcelona, Spain
RECRUITINGResearch Site
Barcelona, Spain
RECRUITING...and 3 more locations
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.