Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) (SANCTUARY)
Lupus Nephritis, Immunoglobulin A Nephropathy
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring glomerulonephritis, IGA, lupus nephritis, complement C5
Eligibility Criteria
Inclusion Criteria:
Common to both disease cohorts:
- Proteinuria ≥1 (gram [g]/day or g/g)
- Vaccinated against meningococcal infection
- Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
For LN cohort:
- Diagnosis of active focal or diffuse proliferative LN Class III or IV
- Clinically active LN, requiring/receiving immunosuppression induction treatment
For IgAN cohort:
- Diagnosis of primary IgAN
- Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria:
Common to both disease cohorts:
- eGFR < 30 milliliters/minute/1.73 meters squared
- Previously received a complement inhibitor (for example, eculizumab)
- Concomitant significant renal disease other than LN or IgAN
- History of other solid organ or bone marrow transplant
- Uncontrolled hypertension
For IgAN cohort:
- Diagnosis of rapid progressive glomerulonephritis
- Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Ravulizumab: LN Cohort
Placebo: LN Cohort
Ravulizumab: IgAN Cohort
Placebo: IgAN Cohort
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Eligible participants will receive placebo IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Eligible participants will receive ravulizumab IV infusion in combination with background therapy during both the Initial Evaluation Period (26 weeks) and Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.
Eligible participants will receive placebo IV infusion in combination with background therapy during the Initial Evaluation Period (26 weeks) and will switch to ravulizumab for the Extension Period (24 weeks). During the Follow-up Period (36 weeks) participants will receive background therapy according to the standard of care.