A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE) - NewPLACE

MorphoSys AG0 个研究点目标入组 22 人2020年8月31日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: MorphoSys AG
入组人数: 22
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年8月31日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

MorphoSys AG

入排标准

入选标准

•1\. Subjects \= 18 to \= 80 years (at date of signing the informed consent form \[ICF]).
•2\. Urine protein to creatinine ratio (UPCR) of \= 3\.0 g/g (as determined by a 24 h urine collection) or proteinuria \= 3\.5 g/24 h (as determined by a 24 h urine collection)
•3\. Anti\-PLA2R antibody positive MN in need for IST according to the investigator’s judgment. The diagnosis of MN should be histologically documented with a diagnostic biopsy; for this purpose, a biopsy at screening or an archival biopsy acquired within 5 years prior to screening is acceptable.
•4\. Estimated glomerular filtration rate (eGFR) \= 50 ml/min/1\.73 m².
•Alternatively, subjects with an eGFR \>30 and \< 50 ml/min/1\.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of \< 25% in a kidney biopsy is histologically documented; for this purpose, a biopsy at screening or an archival biopsy acquired within 6 months prior to start of screening is needed.
•5\. Not in spontaneous remission despite proper treatment with angiotensin\-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
•6\. Systolic blood pressure (BP) \= 150 mmHg and diastolic BP \= 100 mmHg after 5 minutes of rest.
•7\. Serum anti\-PLA2R antibodies \= 50\.0 RU/mL determined by Euroimmun ELISA.
•8\. Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
•a. Not a female of childbearing potential (FCBP) ; OR

排除标准

•1\. Hemoglobin \< 80 g/L (4\.9 mmol/L).
•2\. Thrombocytopenia: Platelets \< 100\.0 x 10^9/L.
•3\. Neutropenia: Neutrophils \< 1\.5 x 10^9/L.
•4\. Leukopenia: Leukocytes \< 3\.0 x 10^9/L.
•5\. B\-cells \< 5 x 10^6/L
•6\. Secondary cause of MN (e.g. malignancies, medications, systemic lupus erythematosus).
•7\. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, immunoglobulin A (IgA) nephropathy).
•8\. Diabetes mellitus type 1\.
•9\. Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and diabetes is controlled, as shown by:
•a. Glycated hemoglobin (HbA1c) \<8\.0 % or 64 mmol/mol.