Clinical trial NCT05136456: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Primary Membranous Nephropathy
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2021-11-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
2. 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)
3. PLA2R-Ab titer ≥20RU/mL at screening
4. 24-hour urinary protein ≥ 3.5g/d at screening
5. Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening

Exclusion Criteria:

1. Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
2. Existence of clinically significant infection within 1 month before screening,
3. Severe or not well controlled other complications
4. Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
5. ALT \> 2 times ULN and/or AST \> 2 times ULN and/or bilirubin \>2 times ULN at screening
6. Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
7. Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;

Primary outcomes:
measure: Proportion of subjects achieving complete or partial remission at week 24
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital affiliated to Southeast University
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Nei Monggol
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Study officials:
References: