IgAN IgAN
Conditions
Interventions
All participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and q8w thereafter for participants weighin
Sponsors
Nakamine Kei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be >= 2 to =1 g/g from the mean of 3 FMVs collected within 1 week during the Screening Period (should be collected at home). 3. eGFR>=30 mL/min/1.73 m2 during Screening as calculated by the CKiD U25 equation (cystatin C) (Pierce, 2021). 4. Adherence to and compliance with stable (weight-adjusted per PI's discretion) and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for >= 3 months prior to Screening with no planned change in dose (weight-adjusted per PI's discretion) during Screening through Week 106. Participants with intolerance to RASI medications may be included. 5. 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.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of rapidly progressive glomerulonephritis as measured by eGFR loss >= 50% over a period of 3 months and/or have > 50% crescents on the kidney biopsy prior to Screening. 2. Secondary forms of IgAN not in the context of primary IgAN or IgAV (eg, due to systemic lupus erythematosus, cirrhosis, or celiac disease). 3. Concomitant clinically significant renal disease other than IgAN or IgAVN. 4. Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months. 5. Uncontrolled diabetes mellitus with HbA1c > 8.5%. 6. History of kidney transplant or planned kidney transplant during the Primary Evaluation Period. 7. History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Primary Evaluation Period or Extension Period, except for corneal transplant. 8. Splenectomy or functional asplenia. 9. Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening. 10. Systemic BP criteria. If = 95th percentile + 12 mm Hg for sex and height or >= 140/90 mm Hg, whichever is lower. If >= 13 years of age: Systemic BP >= 140/90 mm Hg. 11. Hemolytic uremic syndrome diagnosed any time prior to Screening. 12. Planned urological surgery expected to influence kidney function within the study time frame. 13. Congenital immunodeficiency. 14. History of unexplained, recurrent infection. 15. Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study. 16. History of or unresolved N meningitidis infection. 17. Known history of HIV, active hepatitis B infection, or active hepatitis C infection. 18. Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment. 19. Drug or alcohol abuse or dependence within 1 year prior to Screening that interferes with ability to participate in the clinical study. 20. History of malignancy within 5 years of Screening, except for nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence. 21. Hypersensitivity to any ingredient contained in the study intervention, including murine proteins. 22. Received biologics for the treatment of IgAN or IgAVN within 6 months prior to Screening. 23. Traditional Chinese medicines and Chinese proprietary medicines with systemic immunosuppressive properties including but not limited to Tripterygium wilfordii or Tripterygium wilfordii-containing medicines for the treatment of IgAN or IgAVN within 6 months prior to Screening. 24. Received a complement inhibitor >= 30 days or 5 half-lives, whichever is longer, prior to Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in proteinuria based on UPCR at Week 34 | — |
Countries
China, Italy, Japan, South Korea, Spain, Taiwan, USA
Contacts
Public ContactKei Nakamine
Alexion Pharma G.K.
Outcome results
None listed