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

Phase 2

Active, not recruiting

• Conditions: Primary Membranous Nephropathy
• Interventions: Drug: SHR1459 Low Dose; Drug: SHR1459 High Dose; Drug: 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.

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-29
• Study Start: 2021-12-15
• Status Verified: 2023-08
• Primary Completion: 2023-08-28
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05
• Study Completion: 2024-03-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

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 & 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

Trial Locations

Locations (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

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