Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients (NCT03461445) | Clinical Trial Compass
CompletedPhase 4
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
United States64 participantsStarted 2018-04-01
Plain-language summary
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
Who can participate
Age range
60 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
. Recipient of a kidney transplant
. Age 60 or greater at the time of transplant
. Kidney graft is functional (not dialysis dependent) by 4 weeks post-transplant
. Have IR tacrolimus as maintenance therapy
. Have BMI \< 35 at time of transplant
. Achieve therapeutic tacrolimus level within 4 weeks post-transplant
Exclusion criteria
. Recipient of a simultaneous non-kidney transplant (pancreas)
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
Change in Neurocognitive Side Effects
Timeframe: 6 weeks after randomization and baseline testing
. Had an episode of rejection before study enrollment
. Had a TIA/CVA after transplantation and before study enrollment
. Had a neurologic injury after transplantation and before study enrollment
. Blindness
. Have an mTOR inhibitor as maintenance therapy
. Nonadherence, as determined by a trough level less than 7 ng/mL after achieving therapeutic level with no other rationale for sub-therapeutic levels.