Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy (NCT05679336) | Clinical Trial Compass
UnknownNot Applicable
Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous Nephropathy
Russia40 participantsStarted 2018-05-01
Plain-language summary
This exploratory study aims to assess the efficacy, safety of the experimental treatment based on a combination of rituximab (RTX), intravenous (IV) cyclophosphamide (CYC), and corticosteroids (S) administrated at lower cumulative doses (RCP) for the induction of early remission in subjects with anti-PLA2R antibody-positive primary membranous nephropathy (PMN) having nephrotic syndrome (NS).
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
. Age 18-75 years.
Exclusion criteria
. Signed informed consent
. Increased serum level of anti-PLA2R antibodies (\>20 RU/ml).
. Absence of contraindications to immusuppressive therapy.
. Presence of nephrotic syndrome (NS) with one of the following conditions:
. persistence for \>6 months despite treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker with or without immunosuppression and NS complications.
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
Partial clinical remission (PR) and complete clinical remission (CR)
Timeframe: Up to 1 year
2
Time to clinical remission
Timeframe: Up to 1 year
Trial details
NCT IDNCT05679336
SponsorSt. Petersburg State Pavlov Medical University
. persistence for \<6 months at the presence of complications related to NS (thromboembolic or infectious event or estimated GFR by CKD-EPI equation (eGFR) decrease \>20%.
. recurrence after remission with a prior immunosuppressive treatment.
. treatment failure of an alternative immunosuppressive regimen.