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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

ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, regardless of gender;

Weight ≥40.0 kg at screening;

Diagnosed as primary membranous nephropathy through kidney biopsy.

Disqualifiers

Secondary membranous nephropathy.

Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.

Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.

Subjects who have a malignant tumor or a history of malignant tumor

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-2173 injection

    Drug

    SHR-2173 injection, with a total of 8 administrations

  • SHR-2173 injection

    Drug

    SHR-2173 injection, with a total of 16 administrations

  • SHR-2173 injection

    Drug

    SHR-2173 injection , with a total of 32 administrations

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BExperimental treatment 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Time frame
Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52
2

12-lead ECG

Time frame
Week4, 8, 12, 24, 28, 36, 52

Secondary outcomes

1

The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)).

Time frame
Week 12, 24, 36, 52
2

The proportion of subjects who achieved CR

Time frame
Week 12, 24, 36, 52
3

The proportion of subjects who achieved PR

Time frame
Week 12, 24, 36, 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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