Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial
Background: Tacrolimus is known to cause neurotoxicities that may be more severe in older individuals. We aimed to compare the neurocognitive side effects of immediate release (IR) and LCP tacrolimus in older kidney transplant recipients in the early post-transplant period. Methods: In this single c...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-09-01
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| Series: | Transplantation Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451959625000083 |
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| author | Hadia Lala Gul Macey Sockolov Katherine Howes Amanpreet Kaur Michelle Occhipinti Heejung Bang Muna Alnimri Yihung Huang Joy Dray Ling-Xin Chen |
| author_facet | Hadia Lala Gul Macey Sockolov Katherine Howes Amanpreet Kaur Michelle Occhipinti Heejung Bang Muna Alnimri Yihung Huang Joy Dray Ling-Xin Chen |
| author_sort | Hadia Lala Gul |
| collection | DOAJ |
| description | Background: Tacrolimus is known to cause neurotoxicities that may be more severe in older individuals. We aimed to compare the neurocognitive side effects of immediate release (IR) and LCP tacrolimus in older kidney transplant recipients in the early post-transplant period. Methods: In this single center, open-label, randomized and controlled trial of 64 kidney transplant recipients aged 60 or above, participants were randomized to LCP tacrolimus or IR tacrolimus between 4- and 8-weeks post-transplantation and followed for 6-weeks. The primary outcome of neurocognitive performance at 6-weeks compared with baseline was assessed by the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). Secondary outcomes included health-related quality of life as measured by the Quality of Life in Essential Tremor Questionnaire (QUEST) and Organ Transplant Symptom and Wellbeing Instrument (OTSWI). Results: 32 patients were randomized to IR tacrolimus and 31 to LCP tacrolimus. In the IR tacrolimus arm, the MOCA score increased by 1.2 points (SD 2.1) and the DSST score increased by 1.0 points (SD 7.8). In the LCP tacrolimus arm, the MOCA score increased by 0.2 points (SD 2.9) and the DSST score increased by 1.3 points (SD 7.5). No statistically significant difference was detected between arms in MOCA, DSST, QUEST or OTSWI scores. There was a trend toward improvement in tremor severity in the LCP tacrolimus arm. Conclusions: No improvement was found in MoCA or DSST performance in patients switched to LCP tacrolimus as compared to IR tacrolimus after 6 weeks of exposure in the early post-transplant period. |
| format | Article |
| id | doaj-art-1e93b4f4046a4e099e2916c51f89e6b6 |
| institution | Kabale University |
| issn | 2451-9596 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Transplantation Reports |
| spelling | doaj-art-1e93b4f4046a4e099e2916c51f89e6b62025-08-20T03:46:49ZengElsevierTransplantation Reports2451-95962025-09-0110310017810.1016/j.tpr.2025.100178Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trialHadia Lala Gul0Macey Sockolov1Katherine Howes2Amanpreet Kaur3Michelle Occhipinti4Heejung Bang5Muna Alnimri6Yihung Huang7Joy Dray8Ling-Xin Chen9Division of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Biostatistics, Department of Public Health Sciences, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United StatesDivision of Transplant Nephrology, Department of Internal Medicine, University of California Davis, Sacramento, CA, United States; Corresponding author at: 4010V Street Suite 2237, Sacramento, CA 95817, United States.Background: Tacrolimus is known to cause neurotoxicities that may be more severe in older individuals. We aimed to compare the neurocognitive side effects of immediate release (IR) and LCP tacrolimus in older kidney transplant recipients in the early post-transplant period. Methods: In this single center, open-label, randomized and controlled trial of 64 kidney transplant recipients aged 60 or above, participants were randomized to LCP tacrolimus or IR tacrolimus between 4- and 8-weeks post-transplantation and followed for 6-weeks. The primary outcome of neurocognitive performance at 6-weeks compared with baseline was assessed by the Montreal Cognitive Assessment (MoCA) and Digit Symbol Substitution Test (DSST). Secondary outcomes included health-related quality of life as measured by the Quality of Life in Essential Tremor Questionnaire (QUEST) and Organ Transplant Symptom and Wellbeing Instrument (OTSWI). Results: 32 patients were randomized to IR tacrolimus and 31 to LCP tacrolimus. In the IR tacrolimus arm, the MOCA score increased by 1.2 points (SD 2.1) and the DSST score increased by 1.0 points (SD 7.8). In the LCP tacrolimus arm, the MOCA score increased by 0.2 points (SD 2.9) and the DSST score increased by 1.3 points (SD 7.5). No statistically significant difference was detected between arms in MOCA, DSST, QUEST or OTSWI scores. There was a trend toward improvement in tremor severity in the LCP tacrolimus arm. Conclusions: No improvement was found in MoCA or DSST performance in patients switched to LCP tacrolimus as compared to IR tacrolimus after 6 weeks of exposure in the early post-transplant period.http://www.sciencedirect.com/science/article/pii/S2451959625000083Kidney transplantOlderTacrolimusNeurocognitionNeurotoxicity |
| spellingShingle | Hadia Lala Gul Macey Sockolov Katherine Howes Amanpreet Kaur Michelle Occhipinti Heejung Bang Muna Alnimri Yihung Huang Joy Dray Ling-Xin Chen Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial Transplantation Reports Kidney transplant Older Tacrolimus Neurocognition Neurotoxicity |
| title | Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial |
| title_full | Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial |
| title_fullStr | Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial |
| title_full_unstemmed | Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial |
| title_short | Effect of tacrolimus formulation on neurocognition in older kidney transplant recipients: A randomized controlled trial |
| title_sort | effect of tacrolimus formulation on neurocognition in older kidney transplant recipients a randomized controlled trial |
| topic | Kidney transplant Older Tacrolimus Neurocognition Neurotoxicity |
| url | http://www.sciencedirect.com/science/article/pii/S2451959625000083 |
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