RecruitingPhase 2/3

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

China216 participantsStarted 2024-07-30

Plain-language summary

To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. Subjects whose laboratory test results meet the prescribed standards during the screening period;
✓. Subjects who have fully understood this study and voluntarily signed the informed consent form；
✓. Subjects who are able to follow the study protocol as judged by the investigator.

✕. 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;
✕. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
✕. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
✕. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;
✕. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;

ORR（Overall Remission Rate）

Timeframe: Approximately 2 years

NCT IDNCT06470191

SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Minghui Zhao

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✓. Subjects whose laboratory test results meet the prescribed standards during the screening period;
✓. Subjects who have fully understood this study and voluntarily signed the informed consent form；
✓. Subjects who are able to follow the study protocol as judged by the investigator.

✕. 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;
✕. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
✕. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
✕. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;
✕. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;