Back to resultsEvaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
Primary Purpose
Primary Membranous Nephropathy
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR1459 Low Dose
SHR1459 High Dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Membranous Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
- Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
- PLA2R-Ab titer ≥20RU/mL at screening
- 24-hour urinary protein ≥ 3.5g/d at screening
- Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
Exclusion Criteria:
- Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
- Existence of clinically significant infection within 1 month before screening,
- Severe or not well controlled other complications
- Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
- ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening
- Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- Zhongshan Hospital Xiamen University
- The People's Hospital of Guangxi Zhuang Autonomous Region
- Henan Provincial People's Hospital
- Xiangya Hospital Central South University
- Jiangsu Province People's Hospital
- Zhongda Hospital affiliated to Southeast University
- Subei People's Hospital of Jiangsu province
- The First Affiliated Hospital of Nanchang University
- The Second Hospital of Jilin University
- The First Affiliated Hospital of Baotou Medical College
- The First Affiliated Hospital of Xi'an Jiaotong University
- Tianjin Medical University General Hospital
- Zhejiang Provincial People's Hospital
- The First Affiliated Hospital of Wenzhou Medical University
- Renji Hospital Shanghai Jiaotong University School of Medicine
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
- Tongji Hospital of Tongji University
- Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
SHR1459 Low Dose
SHR1459 High Dose
Placebo
Arm Description
Drug: SHR1459 SHR1459 oral 24weeks
Drug: SHR0302 SHR1459 oral 24 weeks
Drug: Placebo Placebo oral 24 weeks
Outcomes
Primary Outcome Measures
Proportion of subjects achieving complete or partial remission at week 24
Proportion of subjects achieving complete or partial remission at week 24
Secondary Outcome Measures
Full Information
NCT ID
NCT05136456
First Posted
November 17, 2021
Last Updated
August 31, 2023
Sponsor
Reistone Biopharma Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT05136456
Brief Title
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
Official Title
A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
August 28, 2023 (Anticipated)
Study Completion Date
March 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reistone Biopharma Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
Detailed Description
This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR1459 Low Dose
Arm Type
Active Comparator
Arm Description
Drug: SHR1459 SHR1459 oral 24weeks
Arm Title
SHR1459 High Dose
Arm Type
Active Comparator
Arm Description
Drug: SHR0302 SHR1459 oral 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Placebo oral 24 weeks
Intervention Type
Drug
Intervention Name(s)
SHR1459 Low Dose
Intervention Description
SHR1459 oral tablets taken once daily (QD) for 24weeks
Intervention Type
Drug
Intervention Name(s)
SHR1459 High Dose
Intervention Description
SHR1459 oral tablets taken once daily (QD) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablets taken once daily (QD) for 24 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects achieving complete or partial remission at week 24
Description
Proportion of subjects achieving complete or partial remission at week 24
Time Frame
24 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
PLA2R-Ab titer ≥20RU/mL at screening
24-hour urinary protein ≥ 3.5g/d at screening
Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
Exclusion Criteria:
Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
Existence of clinically significant infection within 1 month before screening,
Severe or not well controlled other complications
Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening
Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province People's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhongda Hospital affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Nei Monggol
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
Country
China
Facility Name
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
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