Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppr… (NCT06676696) | Clinical Trial Compass
RecruitingPhase 4
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
Spain202 participantsStarted 2024-01-22
Plain-language summary
The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
The main question this study aims to answer is:
Does maintaining long-term immunosuppression in patients with a late renal graft failure (\> 3 months) safely reduce the risk of HLA sensitization?
To answer this question, patients will be assigned to a control arm or investigational arm:
* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.
* Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years.
Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
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:
* Patient must be able to understand and provide written informed consent
* Patients older than 18 years who had received at least one previous renal transplant
* Patients with a retained kidney graft failed for any reason which survived at least 3 months
* Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted
* Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria
* Patients taking immunosuppressants tacrolimus or cyclosporine
* cPRA at the time of randomization ≤ 90%
Exclusion Criteria:
* Patients who have received another solid organ transplantation (liver, lung, heart or pancreas)
* Patients waiting for a living related / unrelated kidney transplant
* Graft survival of the failed graft lower than 3 months
* Patients in dialysis more than 6 months at the time of randomization
* Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria
* Pregnant women
* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Patients should use one of the acceptable birth control meas…
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
Degree of HLA sensitization
Timeframe: 2 years
Trial details
NCT IDNCT06676696
SponsorHospital Universitari Vall d'Hebron Research Institute