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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04145440
Registration number
NCT04145440
Ethics application status
Date submitted
18/10/2019
Date registered
30/10/2019
Date last updated
24/02/2025
Titles & IDs
Public title
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
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Scientific title
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)
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Secondary ID [1]
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MOR202C103
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Universal Trial Number (UTN)
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Trial acronym
M-PLACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glomerulonephritis, Membranous
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antiPLA2R Positive
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MOR202
Experimental: Cohort 1 (newly diagnosed or relapsed participants) - Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Experimental: Cohort 2 (refractory participants) - Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
Treatment: Drugs: MOR202
Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [1]
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Week 1 to Week 24
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Primary outcome [2]
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Percentage of Participants With Adverse Events
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Assessment method [2]
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [2]
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Week 1 to Week 24
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Secondary outcome [1]
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Best Immunological Response Rate (BIRR)
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Assessment method [1]
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The BIRR was defined as the percentage of participants with a best immunological response of stringent immunological complete response (sICR), immunological complete response (ICR), or immunological partial response (IPR) prior to the start of prohibited treatment or progression, based on reduction of serum anti-PLA2R antibody titer.
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Timepoint [1]
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Up to 52 weeks
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Secondary outcome [2]
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Number of Participants Tested Positive for Anti-felzartamab Antibodies
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Assessment method [2]
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Timepoint [2]
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Baseline; Up to 52 weeks
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Secondary outcome [3]
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Percentage of Participants Tested Positive for Anti-felzartamab Antibodies
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Assessment method [3]
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Timepoint [3]
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Baseline; Up to 52 weeks
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Secondary outcome [4]
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Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies
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Assessment method [4]
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Timepoint [4]
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Baseline; Up to 52 weeks
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Secondary outcome [5]
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Felzartamab Serum Concentrations After Multiple Intravenous Administrations
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Assessment method [5]
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Timepoint [5]
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Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)
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Secondary outcome [6]
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Number of Participants With AEs During the Follow-up Period
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Assessment method [6]
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [6]
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Week 25 to Week 52
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Secondary outcome [7]
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Percentage of Participants With AEs During the Follow-up Period
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Assessment method [7]
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
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Timepoint [7]
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Week 25 to Week 52
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Eligibility
Key inclusion criteria
Key
* > 18 to < 80 years (at date of signing informed consent form [ICF]).
* Urine protein to creatinine ratio (UPCR) of = 3.000 g/g OR proteinuria = 3.500 g/24 h from 24-h urine at screening
* Active anti-PLA2R antibody positive MN in need of 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.
* Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
* Systolic blood pressure BP =150 mmHg and diastolic BP =100 mmHg after 5 minutes of rest
* Vaccinated against Pneumococcus within the last 5 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 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies =50.0 RU/mL
* Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies = 20.0 RU/mL measured at screening
Note: France will only enroll patients in Cohort 2.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Hemoglobin < 80 g/L.
* Thrombocytopenia: Platelets < 100.0 x 109/L.
* Neutropenia: Neutrophils < 1.5 x 109/L.
* Leukopenia: Leukocytes < 3.0 x 109/L.
* Hypogammaglobulinemia: Serum immunoglobulins = 4.0 g/L.
Subjects may receive supportive therapies to meet the above criteria
* B-cells < 5 x 106/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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2022
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St. George Hospital - Sydney
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Recruitment hospital [2]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [3]
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Western Health - Melbourne
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Recruitment postcode(s) [1]
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2217 - Sydney
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Recruitment postcode(s) [2]
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3050 - Melbourne
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Recruitment postcode(s) [3]
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3021 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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State/province [6]
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Minnesota
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United States of America
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Ohio
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United States of America
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Texas
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Belgium
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Aalst
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Liège
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France
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Bordeaux
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France
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Grenoble
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France
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Lille
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France
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Paris
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France
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Saint-Priest-en-Jarez
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Italy
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Firenze
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Italy
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Milan
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Italy
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Verona
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Seoul
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Netherlands
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Nijmegen
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Poland
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Warsaw
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Poland
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Lódz
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
HI-Bio, A Biogen Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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)
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Trial website
https://clinicaltrials.gov/study/NCT04145440
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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HI-Bio, A Biogen Company
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/40/NCT04145440/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/40/NCT04145440/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04145440
Download to PDF