Abstract: SA-PO1083
Effect of Prolonged-Release vs. Immediate-Release Tacrolimus on Neurocognition in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial (RCT)
Session Information
- Transplantation: Clinical - II
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Lala Gul, Hadia, UC Davis Health, Sacramento, California, United States
- Sockolov, Macey, UC Davis Health, Sacramento, California, United States
- Kaur, Amanpreet, UC Davis Health, Sacramento, California, United States
- Occhipinti, Michelle, UC Davis Health, Sacramento, California, United States
- Bang, Heejung, UC Davis Health, Sacramento, California, United States
- Alnimri, Muna, UC Davis Health, Sacramento, California, United States
- Huang, Yihung, UC Davis Health, Sacramento, California, United States
- Chen, Ling-Xin, UC Davis Health, Sacramento, California, United States
- Howes, Katherine A., UC Davis Health, Sacramento, California, United States
Background
Tacrolimus is known to cause neurological side effects and elderly individuals seem particularly vulnerable. It is unknown if the prolonged-release (PR) tacrolimus (Envarsus XR) formulation minimizes neurocognitive side effects compared to immediate release (IR) tacrolimus due to lower peak serum levels. We aimed to compare the neurocognitive side effects of PR and IR tacrolimus in elderly kidney transplant recipients within the first months post-transplantation.
Methods
In this single center, prospective, open-label, randomized trial, 64 kidney transplant recipients aged 60 or above were randomized to PR tacrolimus or IR tacrolimus between 4 and 8 weeks post-transplantation and followed for 6 weeks. Neurocognitive performance was assessed by the Montreal Cognitive Assessment (MOCA) and Digit Symbol Substitution Test (DSST). Secondary outcomes of tremor and quality of life were assessed through the Quality of Life in Essential Tremor Questionnaire (QUEST) and Organ Transplant Symptom and Wellbeing Instrument (OTSWI).
Results
32 patients were randomized to the IR tacrolimus arm and 31 into the PR tacrolimus arm. Mean age was 69 in both arms and 37% were women. Table 1 shows the assessment scores for the primary and secondary outcomes. There was no statistically significant difference between groups in the change in MOCA or DSST scores from baseline to 6 weeks or in tremor or quality of life measures.
Conclusion
Although prior studies indicated improvement in neurological side effects in PR tacrolimus compared with IR tacrolimus, the improvement does not appear to extend to neurocognitive side effects as assessed by the MOCA or DSST tests in this cohort.
Table 1. Neurocognitive Testing and Tremor Results. P-values were computed from ANCOVA adjusting baseline value and without adjusting for multiplicity. Values shown are mean and (standard deviation).
Funding
- Commercial Support – Veloxis Pharmaceuticals, Inc