Neurocognitive Function and Tacrolimus in Older Kidney Transplant Recipients
This study is looking at how different forms of tacrolimus, a medicine used after kidney transplants, might affect thinking and memory (neurocognitive function) in older adults. If you're an older kidney transplant recipient, this study compares two types of tacrolimus: immediate-release tacrolimus (Prograf®) and extended-release tacrolimus (Envarsus XR). Researchers want to see if switching to Envarsus XR changes your thinking and memory compared to staying on Prograf®. The study aims to enroll 92 participants and will measure changes in neurocognitive function over 12 months. To join, you must be at least 65 years old, have had your kidney transplant at least a year ago, and be taking immediate-release tacrolimus with stable kidney function and drug levels.
- Study design
- This is a randomized controlled study, meaning participants will be assigned by chance to one of two groups. It plans to enroll 92 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Neurocognitive function will be measured at 12 months to see changes over an intermediate term.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Leonardo V. Riella, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score)12 month
Neurocognitive functions will be assessed across multiple cognitive domains using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3. The NIHTB-CB version 3 encompasses seven tests to assess attention, executive function, language, memory, and processing speed. The total cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
- The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score)12 month
The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
- The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score)12 month
The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.
- The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score)12 month
The total composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The total cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.
- The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score)12 month
The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.
- The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score)12 month
The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.