Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

  • End date
    May 15, 2022
  • participants needed
  • sponsor
    MorphoSys AG
Updated on 17 January 2021
Winrich H Rauschning, MD PhD MBA
Primary Contact
CHU Saint Etienne - H pital Nord (0.0 mi away) Contact
+27 other location
immunosuppressive agents
ace inhibitor
glomerular filtration rate
alkylating agents
enzyme inhibitor
angiotensin converting enzyme


This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)


After treatment subjects will be observed for up to 1 year.

Treatment MOR202
Clinical Study IdentifierNCT04145440
SponsorMorphoSys AG
Last Modified on17 January 2021

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Idiopathic Membranous Nephropathy or Membranous glomerulonephritis or antiPLA2R Positive?
Urine protein to creatinine ratio of 3.0 g/g (as measured from a 24 hour urine collection)
Active anti-PLA2R antibody positive MN in need for immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable
Estimated glomerular filtration rate 50 ml/min/1.73m or >30 and <50 ml/min/1.73m, and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening
on supportive treatment with an Angiotensin Converting Enzyme Inhibitor or an Angiotensin II Receptor Blocker for at least 4 weeks prior to Screening, having reached a stable dose
Systolic BP 150 mmHg and diastolic BP 100 mmHg
Vaccinated against Pneumococcus within the last 3 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days)
Cohort 1a (newly diagnosed patients): Serum anti-PLA2R antibodies 150.0 Response Units(RU)/mL determined at screening by Euroimmun ELISA
Cohort 1b, relapse subjects: Must have had complete immunological and/or clinical remission according to judgement of the investigator and serum anti-PLA2R antibodies 50.0 RU/mL determined at screening by Euroimmun ELISA
Cohort 2: Failure of previous therapy, i.e. subject never achieved a complete immunological and/or clinical remission according to judgement of the investigator. during or after completion of a recognized IST containing cyclosporine A, tacrolimus, mycophenolate-mofetil, ACTH or alkylating agents (e.g. cyclophosphamide), or rituximab. Serum anti-PLA2R antibodies 20.0 RU/mL determined at screening by the Euroimmun ELISA

Exclusion Criteria

Hemoglobin <90 g/L
Thrombocytopenia: Platelets <100.0x109/L
Neutropenia: Neutrophils <1.5x109/L
Leukopenia: Leukocytes <3.0x109/L
Hypogammaglobulinemia: Serum immunoglobulins 5.0 g/L
Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)
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