EUCTR2019-000780-24-NL
Active, not recruiting
Phase 1
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE - M-PLACE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary (anti-PLA2R antibody positive) Membranous Nephropathy
- Sponsor
- MorphoSys AG
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. \=18 to \=80 years (at date of signing ICF)
- •2\. Urine protein to creatinine ratio (UPCR) of \= 3\.0000 g/g OR proteinuria \= 3\.500 g/24 h from 24\-hr urine at screening
- •3\. Active and anti\-PLA2R antibody positive MN in need for IST according
- •to investigator judgement and with diagnostic biopsy, archival biopsy
- •acquired within 5 years prior to screening is acceptable
- •4\. Estimated glomerular filtration rate (eGFR) \=50 ml/min/1\.73m² or
- •\>30 and \<50 ml/min/1\.73m², and IFTA (interstitial fibrosis and tub\-ular
- •atrophy) score of less than 25% on a renal biopsy obtained within the
- •last 6 months prior to start of screening. If a subject falls into the latter
- •range without availability of an adequate biopsy, a biopsy at screening
Exclusion Criteria
- •1\. Hemoglobin \< 80 g/L
- •2\. Thrombocytopenia: Platelets \< 100\.0x10^9/L
- •3\. Neutropenia: Neutrophils \< 1\.5x10^9/L
- •4\. Leukopenia: Leukocytes \< 3\.0x10^9/L
- •5\. Hypogammaglobulinemia: Serum immunoglobulins \=4\.0 g/L
- •6\. B\-cells \< 5 x 106/L
- •7\. Secondary cause of MN (e.g. SLE, medications, malignancies) as
- •determined by the investigator
- •8\. Concomitant renal disease other than MN (e.g., diabetic renal disease,
- •lupus nephritis, IgA nephropathy)
Outcomes
Primary Outcomes
Not specified
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