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New treatment option for Primary Membranous Nephropathy
Official title 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
ClinicalTrials.gov ID: NCT05668403
What this study is testing
What is B007?
B007 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary membranous nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people who have fully understood this study and voluntarily signed the informed consent form;
- Male or female people, aged between 18 and 75 years;
- people with primary membranous nephropathy pathologically confirmed by renal biopsy;
- people with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
- If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is...
You likely can't join if
- people with secondary membranous nephropathy;
- people with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
- people with decreases in urine protein ≥ 50% within 6 months before screening;
- people who have received or are receiving renal replacement therapy;
- people with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
- people who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
See the full eligibility criteria
- people who have fully understood this study and voluntarily signed the informed consent form;
- Male or female people, aged between 18 and 75 years;
- people with primary membranous nephropathy pathologically confirmed by renal biopsy;
- people with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;
- If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
- people who are able to follow the study protocol as judged by the investigator.
- people with secondary membranous nephropathy;
- people with uncontrolled blood pressure as judged by the investigator within 3 months before screening;
- people with decreases in urine protein ≥ 50% within 6 months before screening;
- people who have received or are receiving renal replacement therapy;
- people with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;
- people who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
- people with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;
- people with known history of severe allergic reactions to humanized monoclonal antibodies；
- people who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;
- 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...
- people with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;
- people with a history of alcoholism or drug abuse within 12 months;
- people with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;
- people with CD4+ T lymphocyte count \< 300 cells/μL;
- Other conditions unsuitable for participation in this study determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, He'nan, China
- Shijiazhuang, Hebei, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, He'nan, China; Shijiazhuang, Hebei, China; Hangzhou, Zhejiang, China; Beijing, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.