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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Membranous Nephropathy
• Intervention / Treatment: Drug: SHR1459 Low Dose; Drug: SHR1459 High Dose; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clement Popovici; Email: clement.popovici@reistonebio.com
• Study Contact Backup: Name: Lesley Shi; Phone Number: 86 17710157616; Email: lesley.shi@reistonebio.com

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai, China
    • Renji Hospital Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Tongji Hospital of Tongji University
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Fujian
    • Xiamen, Fujian, China
      • Zhongshan Hospital Xiamen University
  • Guangxi
    • Nanning, Guangxi, China
      • The people's hospital of Guangxi Zhuang Autonomous Region
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province People's Hospital
    • Nanjing, Jiangsu, China
      • Zhongda Hospital Affiliated to Southeast University
    • Yangzhou, Jiangsu, China
      • Subei People's Hospital of Jiangsu province
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The first affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
  • Nei Monggol
    • Baotou, Nei Monggol, China
      • The first affiliated hospital of Baotou medical college
  • Shanxi
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SHR1459 Low Dose; Drug: SHR1459 SHR1459 oral 24weeks	Drug: SHR1459 Low Dose; SHR1459 oral tablets taken once daily (QD) for 24weeks
Active Comparator: SHR1459 High Dose; Drug: SHR0302 SHR1459 oral 24 weeks	Drug: SHR1459 High Dose; SHR1459 oral tablets taken once daily (QD) for 24 weeks
Placebo Comparator: Placebo; Drug: Placebo Placebo oral 24 weeks	Drug: Placebo; Placebo oral tablets taken once daily (QD) for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving complete or partial remission at week 24	Proportion of subjects achieving complete or partial remission at week 24	24 Weeks

Collaborators and Investigators

• Sponsor: Reistone Biopharma Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): August 28, 2023
• Study Completion (Estimated): March 11, 2024

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, Membranous
• Other Study ID Numbers: RSB20926

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No