A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Ne… (NCT07029139) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy
156 participantsStarted 2025-06-30
Plain-language summary
This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy.
The study has two parts. Part one is dose escalation part, and Part two is dose expansion part.
Who can participate
Age range
18 Years – 80 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
. The age range is between 18 and 80 years old, regardless of gender.
. Diagnosed with primary membranous nephropathy by renal biopsy during the screening/induction period or within 24 months before screening. Pathological reports must be reviewed by the investigator prior to study drug administration.
. The glomerular filtration rate (eGFR) estimated by CKD-EPI formula is ≥ 40ml/min/1.73m\^2, or the endogenous creatinine clearance rate (CrCl) based on 24-hour urine examination is ≥ 40ml/min.
. Participants taking angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists must maintain a stable dose for at least 4 weeks before screening;
. Participants with systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening.
. During the screening period and the baseline visit, the 24-hour urine protein is \> 3.5g.
. Have never received immunosuppressive therapy for PMN (cyclophosphamide, calcineurin inhibitors, such as cyclosporine and tacrolimus) and B cell exhaustion therapy (such as rituximab); or relapsed after receiving the above treatment to achieve complete remission or partial remission (comprehensively judged and recorded by the researcher), and have not received the above treatment after recurrence (excluding those who are ineffective or resistant to B cell depletion drugs).
. Have fully understood this study and voluntarily signed the informed consent form.
Exclusion criteria
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.
. Diagnostic renal biopsy shows evidence of glomerular crescent formation, which suggests the diagnosis of other renal diseases or renal biopsy evidence of interstitial fibrosis/tubular atrophy in cortical area \> 50%.
. Uncontrolled blood pressure as judged by the investigator within the 3 months prior to screening.
. Individuals with evidence of a ≥50% decrease in urine protein within the first 6 months before screening.
. Currently undergoing or planning to undergo renal replacement therapy during the study period.
. Type 1 diabetes or type 2 diabetes with diabetic nephropathy (confirmed by renal biopsy report) or without biopsy-confirmed diabetic nephropathy but with a diabetes duration ≥5 years.
. Presence of severe, progressive, or uncontrolled comorbidities.
. Individuals who have had or currently have malignant tumors.