Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
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)
1 other identifier
interventional
61
1 country
19
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2021
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
November 29, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2024
CompletedSeptember 5, 2023
August 1, 2023
1.7 years
November 17, 2021
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving complete or partial remission at week 24
Proportion of subjects achieving complete or partial remission at week 24
24 Weeks
Study Arms (3)
SHR1459 Low Dose
ACTIVE COMPARATORDrug: SHR1459 SHR1459 oral 24weeks
SHR1459 High Dose
ACTIVE COMPARATORDrug: SHR0302 SHR1459 oral 24 weeks
Placebo
PLACEBO COMPARATORDrug: Placebo Placebo oral 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
- hour urinary protein ≥ 3.5g/d at screening
- Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Nei Monggol, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Tongji Hospital of Tongji University
Shanghai, China
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai, China
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
November 29, 2021
Study Start
December 15, 2021
Primary Completion
August 28, 2023
Study Completion
March 11, 2024
Last Updated
September 5, 2023
Record last verified: 2023-08