Phase 4
Completed N=64
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Kidney Transplant; Complications · Toxicity · Drug Toxicity · Neurotoxicity
Source: ClinicalTrials.gov NCT03461445 ↗
Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Apr 2025
Primary outcomePrimary: Change in Neurocognitive Side Effects — 1.2; 0.2; 1.0; 1.26 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neurocognitive Side Effects |
1.2; 0.2; 1.0; 1.26 | — |
| SECONDARY Change in Self-reported Side Effects |
-1.2; -3.1 | — |
| SECONDARY Kidney Graft Survival |
32; 32 | — |
| SECONDARY Patient Survival |
32; 32 | — |
Eligibility Criteria
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)
- 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.
- Adults unable to consent
- Pregnant women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT03461445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.