About this trial
To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
Subjects with glomerular filtration rate(eGFR) ≥ 45 mL/min/1.73 m2.
If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization;
Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
Disqualifiers
Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
Subjects who have received medication prescribed for membranous nephropathy;
Subjects with concomitant prescribed diseases;
Trial design
Parallel
Treatments tested in this trial
B007
DrugB007: Subcutaneous injection was administered on days 1 and 15
Cyclosporin Capsules
DrugCyclosporin Capsules: Orally, 3.5 mg/kg/d;
Treatment groups
Trial outcomes
Primary outcomes
ORR(Overall Remission Rate)
Secondary outcomes
CRR(Complete Remission Rate)
PRR(Partial Remission Rate)
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Sponsors and contacts
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Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborator