Berger's disease Kidney disease
Conditions
Interventions
Ravulizumab is formulated at pH 7.0 and is supplied in 30 mL single-use vials.
Each vial of ravulizumab contains 300 mg of ravulizumab (10 mg/mL) in 10 mM
sodium phosphate, 150 mM sodium chloride, 0
Sponsors
Alexion Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Common to both disease cohorts: - 18 - 75 years of age - Proteinuria >= 1 (g/d or g/g) - Vaccinated against meningococcal infection - Vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae For LN cohort: - Diagnosis of active focal or diffuse proliferative LN Class III or IV - Clinical active LN, requiring/receiving immunosuppression induction treatment For IgAN cohort: - Diagnosis of primary IgAN - Compliance with stable and optimal dose of RAS inhibitor treatment for >= 3 months - For participants with a kidney biopsy used for eligibility > 1 year prior to Screening : Presence of hematuria as defined by a positive result on urine dipstick for blood or >= 10 red blood cell (RBC)/hpf microscopy on urine sediment (as documented by the local laboratory). Presence of hematuria documented by the central laboratory may also be acceptable. Participants with established intolerance to RAS inhibitors may be included
Exclusion criteria
Exclusion criteria: Common to both disease cohorts: - Estimated GFR < 30 mL/min/1.73 m2 - For patients with eGFR < 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior or during the Screening Period: >= 50% interstitial fibrosis and tubular atrophy >= 50% glomerular sclerosis, >= 50% active crescent formation - Previously received a complement inhibitor (eg, eculizumab) at any time - Concomitant significant renal disease other than LN or IgAN - History of other solid organ or bone marrow transplant - Uncontrolled hypertension - Institutionalization by administrative or court order or known medical or psychological condition or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study. Known history of humane immunodeficiency virus (HIV) infection - Hypersensitivity to any ingredient contained in the study drug For LN cohort: -Participants who have initiated any of the following treatments for the current active LN flare : a. Cyclophosphamide = 4 consecutive weeks prior to Screening e. Oral corticosteroids >= 0.5 mg/kg/day for >= 4 consecutive weeks prior to Screening For IgAN cohort: - Diagnosis of rapid progressive glomerulonephritis - Prednisone or prednisone equivalent > 20 mg/day for > 14 consecutive days or any other systemic immunosuppression for the treatment of IgAN =38 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percentage change in proteinuria | — |
Secondary
| Measure | Time frame |
|---|---|
| Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR For LN: - Percentage of participants meeting the criteria for Complete Renal Response - Percentage of participants meeting the criteria for Partial Renal Response - Time to UPCR (Urine Protein to Creatinine Ratio) < 0.5 g/g - Percentage of participants achieving corticosteroid taper to 7.5 mg/day - Percentage of participants with Renal Flare - Percentage of participants with Extrarenal SLE (Systemic Lupus Erythematosus) Flare -Percentage of participants with Suboptimal Response through Week 50 For IgAN: - Percentage of participants meeting the criteria for Partial Remission | — |
Countries
Netherlands
Outcome results
None listed