Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Primary Membranous Nephropathy

Treatments: Drug: SHR-2173 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07289763

SHR-2173-201

Details and patient eligibility

About

To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75 years, regardless of gender;
2. Weight ≥40.0 kg at screening;
3. Diagnosed as primary membranous nephropathy through kidney biopsy.

Exclusion criteria

1. Secondary membranous nephropathy.
2. Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.
3. Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.
4. Subjects who have a malignant tumor or a history of malignant tumor
5. Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR-2173 injection

Drug: SHR-2173 injection

Drug: SHR-2173 injection

Treatment group B

Experimental group

Treatment:

Drug: SHR-2173 injection

Drug: SHR-2173 injection

Drug: SHR-2173 injection

Treatment group C

Experimental group

Treatment:

Drug: SHR-2173 injection

Drug: SHR-2173 injection

Drug: SHR-2173 injection