A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • B007

    Drug

    B007: Subcutaneous injection was administered on days 1 and 15

  • Cyclosporin Capsules

    Drug

    Cyclosporin Capsules: Orally, 3.5 mg/kg/d;

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: B007Experimental treatment 1 intervention
Group B: Cyclosporin CapsulesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ORR(Overall Remission Rate)

Time frame
Approximately 2 years

Secondary outcomes

1

CRR(Complete Remission Rate)

Time frame
Approximately 2 years
2

PRR(Partial Remission Rate)

Time frame
Approximately 2 years
3

Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

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Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator