Study of Ravulizumab in Pediatric Participants With Primary IgAN

Korábbi kezelés

• Concomitant clinically significant renal disease other than IgAN or IgAVN
• Hemolytic uremic syndrome diagnosed any time prior to Screening.
• Planned urological surgery expected to influence kidney function within the study time frame.
• 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

Más betegség

• 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

Laborértékek

• Uncontrolled diabetes mellitus with HbA1c > 8.5%
• Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening.

Egyéb

• Diagnosis of rapidly progressive glomerulonephritis
• Secondary forms of IgAN not in the context of primary IgAN or IgAV
• Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months.
• Splenectomy or functional asplenia
• Congenital immunodeficiency

• 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 RAASI (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