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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-03-11

Brief Summary

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

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Detailed Description

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

Conditions

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Primary Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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SHR1459 Low Dose

Drug: SHR1459 SHR1459 oral 24weeks

Group Type ACTIVE_COMPARATOR

SHR1459 Low Dose

Intervention Type DRUG

SHR1459 oral tablets taken once daily (QD) for 24weeks

SHR1459 High Dose

Drug: SHR0302 SHR1459 oral 24 weeks

Group Type ACTIVE_COMPARATOR

SHR1459 High Dose

Intervention Type DRUG

SHR1459 oral tablets taken once daily (QD) for 24 weeks

Placebo

Drug: Placebo Placebo oral 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablets taken once daily (QD) for 24 weeks

Interventions

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SHR1459 Low Dose

SHR1459 oral tablets taken once daily (QD) for 24weeks

Intervention Type DRUG

SHR1459 High Dose

SHR1459 oral tablets taken once daily (QD) for 24 weeks

Intervention Type DRUG

Placebo

Placebo oral tablets taken once daily (QD) for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No