Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN) MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Alexion Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
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 For a full list of inclusion criteria please refer to the clinical study protocol, section 5.1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Common to both disease cohorts: - Estimated GFR 3 g d. Mycophenolate mofetil > 2 g/day (or equivalent) for = 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 immunosuppression for the treatment of IgAN = 6 months prior to Screening - Body mass index = 38 kg/m2 For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with LN or IgAN;Secondary Objective: Safety and tolerability of ravulizumab and additional efficacy measures;Primary end point(s): Percentage change in proteinuria ;Timepoint(s) of evaluation of this end point: Baseline and Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 ;Timepoint(s) of evaluation of this end point: Throughout, Week 26 and/or Week 50 | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactEuropean Clinical Trial Information
Alexion Europe SAS
Outcome results
None listed