Status:
COMPLETED
MOR202 for Refractory MN
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
MorphoSys AG
Conditions:
Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Membranous nephropathy (MN) - the leading cause of nephrotic syndrome (NS) in adults - is an immune-mediated disease that results from the deposition of immunoglobulins and complement components onto ...
Eligibility Criteria
Inclusion
- 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 significant (i.e. more than 2 weeks) immunosuppressive therapy over the last 6 months.
- Written informed consent.
Exclusion
- 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).
- 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.
- 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 (https://www.hma.eu/fileadmin/dateien/Human\_Medicines/01-About\_HMA/Working\_Groups/CTFG/2020\_09\_HMA\_CTFG\_Contraception\_guidance\_Version\_1.1\_updated.pdf).
- Legal incapacity or limited legal capacity.
Key Trial Info
Start Date :
October 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04893096
Start Date
October 22 2021
End Date
February 21 2025
Last Update
March 25 2025
Active Locations (2)
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1
ASST HPG23 - Unità di Nefrologia
Bergamo, BG, Italy, 24100
2
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
Ranica, BG, Italy, 24020