Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
- Conditions
- Primary Membranous Nephropathy
- Interventions
- Drug: SHR1459 Low DoseDrug: SHR1459 High DoseDrug: Placebo
- Registration Number
- NCT05136456
- Lead Sponsor
- Reistone Biopharma Company Limited
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 61
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR1459 Low Dose SHR1459 Low Dose Drug: SHR1459 SHR1459 oral 24weeks SHR1459 High Dose SHR1459 High Dose Drug: SHR0302 SHR1459 oral 24 weeks Placebo Placebo Drug: Placebo Placebo oral 24 weeks
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving complete or partial remission at week 24 24 Weeks Proportion of subjects achieving complete or partial remission at week 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, Nei Monggol, China
Zhongshan Hospital Xiamen University
🇨🇳Xiamen, Fujian, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jiangsu Province People's Hospital
🇨🇳Nanjing, Jiangsu, China
Subei People's Hospital of Jiangsu province
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Renji Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Zhongda Hospital affiliated to Southeast University
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China