Rescue Therapy with the Human Anti-CD38 Antibody MOR202 (felzartamab) in Patients with Membranous Nephropathy who Failed Anti-CD20 Target Therapy (MONET study)
- Conditions
- Membranous nephropathyMedDRA version: 21.1Level: LLTClassification code: 10027170Term: Membranous nephropathy Class: 10038359Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-513744-28-00
- Lead Sponsor
- Istituto Di Ricerche Farmacologiche Mario Negri
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Age =18 years, Biopsy-proven membranous nephropathy with or without detectable circulating anti-PLA2R or anti-THSD7A antibodies, Background treatment with RAS blocking agents (ACE inhibitor and/or ARBs), at maximum tolerated doses and adequately controlled blood pressure (BP <140/90 mmHg in at least three consecutive readings at screening)., One condition between: • Anti-CD20 Resistance: residual proteinuria =3.5 g/day (mean of three consecutive 24-hour urine collections), with less than 50% reduction compared to pre-treatment values at least 12 months after anti-CD20 antibody therapy. • Anti-CD20 Dependence: frequently relapsing NS (nephrotic-range proteinuria for >50% of time in the last five years or since disease onset, whichever is shorter) despite repeated treatments with anti-CD20 antibodies., Estimated GFR >30 ml/min/1.73m2 (CKD-EPI equation) and less than 50% of sclerotic glomeruli in patients receiving renal biopsy., A minimum 12-month wash-out from last anti-CD20 therapy with rituximab and/or other monoclonal antibodies, No immunosuppressive therapy with steroid, cyclophosphamide, cyclosporine, mycophenolate mofetil or any other immunosuppressant over the last 6 months; in case of therapies administered for less than 2 weeks, no washout time will be required prior to inclusion., Completed anti SARS Cov 2 Vaccination, Written informed consent
Clinically relevant neutropenia (neutrophils < 1.5 x 109/L), anemia (Hb levels <9.0 g/dL), thrombocytopenia (platelet count < 150.000/mm3), increased liver transaminase or bilirubin levels (total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN)., Participation in other clinical trials within 4 weeks of signing the consent form, Expected need of anti SARS Cov 2 vaccination during the study period, Pregnancy or breast-feeding, Childbearing potential in males and females non using an highly effective method of contraception according to 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials, Legal incapacity or limited legal capacity, Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events over the last three months) or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator., Clinically relevant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening, History of significant cerebrovascular disease (stroke or transitory ischemic attack over the last three months) or sensory or motor neuropathy of toxicity = grade 3., Any clinical condition that in the investigator judgment could affect the possibility to complete the study or could have a major confounding effect on study findings and data interpretation, Known intolerance to the study drug or its excipients, Any viral, bacterial or fungal infection without complete symptoms resolution from at least two weeks, Serologic or virologic markers positive for HIV, hepatitis C (patients with positive antihepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen [HBsAg] are excluded). Patients with isolated positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll., History of malignancy within the prior 5 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method