Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy

Primary Membranous Nephropathy Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05136456
• Other study ID #: RSB20926
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: March 11, 2024

Study information

• Verified date: August 2023
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Description:

This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: March 11, 2024
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Diseases
• Primary Membranous Nephropathy

Intervention

Drug:
• SHR1459 Low Dose
SHR1459 oral tablets taken once daily (QD) for 24weeks
• SHR1459 High Dose
SHR1459 oral tablets taken once daily (QD) for 24 weeks
• Placebo
Placebo oral tablets taken once daily (QD) for 24 weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Nei Monggol
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province People's Hospital	Nanjing	Jiangsu
China	Zhongda Hospital affiliated to Southeast University	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
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	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving complete or partial remission at week 24	Proportion of subjects achieving complete or partial remission at week 24	24 Weeks