Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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
- * 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
Ages Eligible for Study
2 Years to 18 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No