Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
- Conditions
- Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)
- Registration Number
- 2023-507977-16-00
- Lead Sponsor
- Alexion Pharmaceuticals Inc.
- Brief Summary
Efficacy of ravulizumab compared with placebo in adult participants with LN and IgAN
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 87
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 a full list of inclusion criteria please refer to the clinical study protocol, section 5.1.
Common to both disease cohorts: - Estimated GFR < 30 mL/min/1.73 m^2 - Previously received a complement inhibitor (eg, eculizumab) at any time - Concomitant significant renal disease other than LN or IgAN - History of kidney transplant or planned kidney transplant during the Treatment Period - History of other solid organ or bone marrow transplant - Uncontrolled hypertension For IgAN cohort: - Diagnosis of rapid progressive glomerulonephritis - Prednisone or prednisone equivalent > 20 mg for > 14 consecutive days or any other immunosuppression within 6 months For a full list of exclusion criteria please refer to the clinical study protocol, section 5.2.
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in proteinuria Percentage change in proteinuria
- Secondary Outcome Measures
Name Time Method Common to both disease cohorts: - Percentage change in proteinuria - Change from baseline in eGFR 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 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
For IgAN: - Percentage of participants meeting the criteria for Partial Remission For IgAN: - Percentage of participants meeting the criteria for Partial Remission
Trial Locations
- Locations (31)
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
Umed Clinical Trials Sp. z o.o.
🇵🇱Lodz, Poland
Universitaetsklinikum Essen AöR
🇩🇪Essen, Germany
Charite Universitaetsmedizin Berlin KöR
🇩🇪Berlin, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Universitaetsklinikum Schleswig-Holstein AöR
🇩🇪Luebeck, Germany
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷St Etienne Cedex 2, France
Hopital Tenon
🇫🇷Paris Cedex 20, France
Centre Hospitalier Universitaire De Montpellier
🇫🇷Montpellier, France
Scroll for more (21 remaining)University Hospital Maastricht🇳🇱Maastricht, NetherlandsPieter Van PaassenSite contact+310433881436p.vanpaassen@maastrichtuniversity.nl