Back to resultsA Clinical Study of MIL62 in Primary Membranous Nephropathy
Primary Purpose
Primary Membranous Nephropathy
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MIL62
Cyclosporine
Sponsored by
About this trial
This is an interventional treatment trial for Primary Membranous Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Adult patients, ≥18 years of age;
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
- Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein > 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
- eGFR ≥40 mL/min/1.73m^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m^2 based on 24-hour urine collection during screening；
- Sufficient organ function;
- Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion Criteria:
- Participants with a secondary cause of MN；
- Cyclosporine resistance；
- Urine protein decreased by > 50% within 6 months before screening；
- Received treatment drugs for membranous nephropathy；
- Concomitant with other serious diseases；
- Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
- Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
- Other exclusion criteria may apply；
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MIL62
Ciclosporin
Arm Description
Outcomes
Primary Outcome Measures
Stage 1: Percentage of Participants with Adverse Events
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Stage 2: Overall response rate (CR+PR) at Week 76
Percentage of Participants with complete and partial response as assessed by the investigator.
Secondary Outcome Measures
Stage 2: complete response, partial response, and overall response (CR+PR) at 104 weeks
Percentage of Participants with complete and partial response as assessed by the investigator.
Stage 2: Complete response rate, partial response rate and overall response rate at 24 weeks and 52 weeks (CR+PR)
Percentage of Participants with complete 、partial response as assessed by the investigator.
Full Information
NCT ID
NCT05398653
First Posted
May 26, 2022
Last Updated
August 9, 2023
Sponsor
Beijing Mabworks Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05398653
Brief Title
A Clinical Study of MIL62 in Primary Membranous Nephropathy
Official Title
A Multicenter, Randomized, Controlled, Open Phase Ib/ Ⅱ Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nephropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Mabworks Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group. Tolerance to MIL62 was evaluated within 4 weeks after the first administration. If the overall safety is determined by the investigator and sponsor to be tolerable to MIL62, phase II enrollment will be initiated.
The second stage was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 30 subjects in each group, to evaluate the efficacy of MIL62 and cyclosporine in the treatment of primary membranous nephropathy. Eligible subjects in both phases received treatment and follow-up for a total of 104 weeks. The 76-week overall response rate was the primary endpoint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Membranous Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIL62
Arm Type
Experimental
Arm Title
Ciclosporin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MIL62
Intervention Description
An intravenous (IV) infusion of 600 mg of MIL62 will be administered at Week 1，Week 3.If the treatment is effective, MIL62 will continue be administered at W25，W27.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d, divided into 2 doses, try to give every 12 hours.The dose was adjusted according to the blood concentration of cyclosporine monitored every 2 weeks ±3 days until the target blood concentration of 125~175 ng/ mL was reached.Cyclophosphamide will be maintained for 12 months, after which the dose was reduced by about 1/3 to 1/2 of the original dose each month, and discontinued after 2 months.
Primary Outcome Measure Information:
Title
Stage 1: Percentage of Participants with Adverse Events
Description
Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.
Time Frame
up to 2year after enrollment
Title
Stage 2: Overall response rate (CR+PR) at Week 76
Description
Percentage of Participants with complete and partial response as assessed by the investigator.
Time Frame
Week 76
Secondary Outcome Measure Information:
Title
Stage 2: complete response, partial response, and overall response (CR+PR) at 104 weeks
Description
Percentage of Participants with complete and partial response as assessed by the investigator.
Time Frame
Week 104
Title
Stage 2: Complete response rate, partial response rate and overall response rate at 24 weeks and 52 weeks (CR+PR)
Description
Percentage of Participants with complete 、partial response as assessed by the investigator.
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, ≥18 years of age;
Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein > 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
eGFR ≥40 mL/min/1.73m^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m^2 based on 24-hour urine collection during screening；
Sufficient organ function;
Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion Criteria:
Participants with a secondary cause of MN；
Cyclosporine resistance；
Urine protein decreased by > 50% within 6 months before screening；
Received treatment drugs for membranous nephropathy；
Concomitant with other serious diseases；
Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
Other exclusion criteria may apply；
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minghui Zhao, doctor
Phone
8610-83572388
Email
mhzhao@bjmu.edu.cn
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minghui Zhao, doctor
Phone
8610-83572388
Email
mhzhao@bjmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of MIL62 in Primary Membranous Nephropathy
We'll reach out to this number within 24 hrs