A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy
Launched by SHANGHAI JIAOLIAN DRUG RESEARCH AND DEVELOPMENT CO., LTD · Dec 20, 2022
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment for Primary Membranous Nephropathy, a kidney condition that can lead to serious health issues. Researchers are testing a type of medication called a monoclonal antibody, which is delivered through an injection under the skin. The main goals of this study are to determine how safe the medication is, how well it works, and how the body processes it.
To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with Primary Membranous Nephropathy confirmed by a kidney biopsy. Participants need to have stable blood pressure and should not have certain other health conditions, such as uncontrolled blood pressure or infections. Those who join the study will receive the treatment and be closely monitored by medical professionals to ensure their safety and gather important information about the treatment's effects. It’s important to know that this trial is currently recruiting participants, and anyone interested should discuss it with their healthcare provider to see if they qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subjects who have fully understood this study and voluntarily signed the informed consent form;
- • 2. Male or female subjects, aged between 18 and 75 years;
- • 3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;
- • 4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
- • 5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
- • 6. Subjects who are able to follow the study protocol as judged by the investigator.
- Exclusion Criteria:
- • 1. Subjects with secondary membranous nephropathy;
- • 2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
- • 3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;
- • 4. Subjects who have received or are receiving renal replacement therapy;
- • 5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
- • 6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
- • 7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
- • 8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies;
- • 9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
- • 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. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
- • 12. Subjects with a history of alcoholism or drug abuse within 12 months;
- • 13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
- • 14. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
- • 15. Other conditions unsuitable for participation in this study determined by the Investigator.
About Shanghai Jiaolian Drug Research And Development Co., Ltd
Shanghai Jiaolian Drug Research and Development Co., Ltd. is a leading biopharmaceutical company based in Shanghai, specializing in the research, development, and commercialization of innovative therapeutics. With a robust pipeline focused on addressing unmet medical needs across various therapeutic areas, the company leverages advanced technologies and a dedicated team of experts to drive drug discovery and development processes. Committed to enhancing patient outcomes, Shanghai Jiaolian actively collaborates with academic institutions and industry partners to bring novel treatments to market while adhering to the highest standards of quality and regulatory compliance.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Zhengzhou, Henan, China
Shijiazhuang, Hebei, China
Beijing, , China
Hangzhou, Zhejiang, China
Shanghai, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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