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

Reistone Biopharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Primary Membranous Nephropathy

Treatments: Drug: Placebo; Drug: SHR1459 High Dose; Drug: SHR1459 Low Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05136456

RSB20926

Details and patient eligibility

About

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

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 3 patient groups, including a placebo group

SHR1459 Low Dose

Active Comparator group

Description:

Drug: SHR1459 SHR1459 oral 24weeks

Treatment:

Drug: SHR1459 Low Dose

SHR1459 High Dose

Active Comparator group

Description:

Drug: SHR0302 SHR1459 oral 24 weeks

Treatment:

Drug: SHR1459 High Dose

Placebo

Placebo Comparator group

Description:

Drug: Placebo Placebo oral 24 weeks

Treatment:

Drug: Placebo