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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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/1.73m² or >30 and < 50 ml/min/1.73m², 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 < 100.0x10^9/L.
  • Neutropenia: Neutrophils < 1.5x10^9/L.
  • Leukopenia: Leukocytes < 3.0x10^9/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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Open for enrollment

Contact information:

Vladimir Chernitskiy CCRP

(507) 255-0231

Chernitskiy.Vladimir@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20493019

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