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

Launched by SHANGHAI JIAOLIAN DRUG RESEARCH AND DEVELOPMENT CO., LTD · Jun 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called B007 for patients with Primary Membranous Nephropathy, a kidney condition that can cause protein to leak into the urine and lead to serious health issues. The study aims to determine how effective and safe B007 is for managing this disease. It is currently recruiting participants aged between 18 and 75 years who have been diagnosed with this condition through a kidney biopsy and have a certain level of kidney function. Eligible participants should also be stable on any current medications related to their condition for at least four weeks before joining the study.

If you decide to participate, you will be closely monitored throughout the trial to assess how well B007 works and to check for any side effects. It’s important to note that certain individuals, like those with specific other health issues or who have had allergic reactions to similar treatments, may not be eligible to join. Before enrolling, participants will need to fully understand the study and provide their consent. This trial offers a chance to contribute to research that could help improve treatment options for people with Primary Membranous Nephropathy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
• • 2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2.
• • 3. 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;
• • 4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;
• • 5. Subjects whose laboratory test results meet the prescribed standards during the screening period;
• • 6. Subjects who have fully understood this study and voluntarily signed the informed consent form；
• • 7. Subjects who are able to follow the study protocol as judged by the investigator.
• Exclusion Criteria:
• • 1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;
• • 2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;
• • 3. Subjects who have received medication prescribed for membranous nephropathy;
• • 4. Subjects with concomitant prescribed diseases;
• • 5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;
• • 6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
• • 7. 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;
• • 8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
• • 9. Subjects with CD4+ T lymphocyte count \< 400 cells/μL;
• • 10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;
• • 11. For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses;
• • 12. Other conditions unsuitable for participation in this study determined by the Investigator.