Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Re… (NCT01289301) | Clinical Trial Compass
UnknownPhase 4
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
Germany124 participantsStarted 2011-10
Plain-language summary
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
Who can participate
Age range
18 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:
* preceding renal transplantation
* functioning graft with a permanent creatinine clearance of more than 25mL/min
* biopsy-confirmed polyoma BK virus nephropathy
* age over 18 years old
Exclusion Criteria:
* allergy or non-tolerance of the study medication everolimus
* pregnancy
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.
1This trial is specifically looking at changing immunosuppression when BK virus infection is detected after a kidney transplant — is my situation similar enough that this approach could even be relevant to my care?
2Since the primary outcome being measured is death or graft loss, what does that tell you about how serious BK virus infection is considered as a threat to my transplanted kidney, and how does that compare to the risk of reducing my anti-rejection medications?
3This is a Phase 4 trial, which I understand means the drugs involved are already approved — does that mean there is more known about the safety of this approach than in earlier-phase studies, and what does the existing evidence suggest about adjusting immunosuppression for BK virus?
4The recruitment status for this trial is listed as unknown — is this study still actively enrolling patients, and if not, are there other similar studies or standard-of-care protocols that follow the same approach I could benefit from instead?
5If I were to discuss participating in this trial with you, how would we monitor both my BK virus levels and my kidney function to make sure we catch any signs of rejection or graft damage as early as possible?
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.