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

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

Treatments tested in this trial

  • B007
  • Cyclosporin Capsules

Treatment groups

216 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator