A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy (NCT06642909) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase II Study of Zuberitamab Injection in Patients With Primary Membranous Nephropathy
China135 participantsStarted 2024-11-13
Plain-language summary
This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the informed consent form and be able to complete the trial according to the protocol;
. The age range is between 18 and 75 years old (including the critical value, subject to the day of signing the informed consent form), regardless of gender;
. Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy before or during screening;
. During the screening period and baseline visit, the urinary protein/creatinine ratio (UPCR) based on 24-hour urine collection should be ≥ 3.5 g/g;
. The estimated glomerular filtration rate (eGFR) using the CKD-EPI formula is ≥ 40mL/min/1.73m2;
. If you are taking angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor antagonists (ARBs), you need to maintain a stable dosage for at least 4 weeks before screening;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76
. Women with fertility who have a negative pregnancy test during the screening period and before the first treatment with the investigational drug (D1 \[allowed -7-day time window\]) must agree to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last administration; Women with fertility include all women who have had their first menstrual period and have not undergone sterilization procedures (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or have not yet reached menopause. Menopausal women are defined as having amenorrhea for at least 12 consecutive months without any other reason; Women with irregular menstrual cycles undergoing hormone replacement therapy (HRT) and serum follicle stimulating hormone (FSH) levels\>35 mIU/mL; Women who are using oral, implanted, or injectable contraceptives, or using methods such as intrauterine devices, vaginal diaphragms, condoms, and spermicides for contraception, or women who have limited sexual activity and have had their sexual partners sterilized (such as vasectomy), should be considered to have fertility.
. People with type 1 diabetes or type 2 diabetes with diabetic nephropathy (type 2 diabetics need to have renal biopsy reports within 1 year before screening).
. Individuals with severe allergies to rituximab or other human mouse chimeric antibodies in the past (such as anaphylactic shock and angioedema) or known allergies to any ingredients or excipients of the investigational drug.
. Individuals who have previously been resistant to cyclosporine or cyclophosphamide, or resistant to CD20 or any other therapy that leads to B cell depletion (ineffective) are identified by investigators.
. Individuals with evidence of a \>50% decrease in urine protein/creatinine ratio within the first 6 months of screening .
. There is no evidence during the screening period to suggest that the patient is positive for PMN related antibodies.
. Any of the following abnormal laboratory test results during screening: a. Abnormal liver function, defined as AST or ALT values\>2 x upper limit of normal (ULN), or total bilirubin values\>1.5 x ULN; b. Total white blood cell count\<3.0 x 109/L, absolute neutrophil count\<1.5 x 109/L, platelet count\<75 x 109/L, or hemoglobin\<90g/L.
. Virological examination results during screening: a. Hepatitis B surface antigen (HBsAg) positive individuals; b. The patient is negative for hepatitis B surface antigen and positive for hepatitis B core antibody, and the result of further hepatitis B virus DNA test exceeds the upper limit of the hospital's reference value; c. Patients with positive hepatitis C virus (HCV) antibodies and HCV RNA; d. The human immunodeficiency virus (HIV) serum reaction is positive.