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Completed

NCT Number: NCT03461445

Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant; Complications Chemically-Induced Disorders Drug Toxicity Drug-Related Side Effects and Adverse Reactions Nervous System Diseases Neurotoxicity Neurotoxicity Syndromes Poisoning Toxicity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC Davis

Sacramento, California, 95817, United States

About this study

The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Envarsus

Drug

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

IR Tacrolimus

Drug

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Primary outcomes

  1. Change in Neurocognitive Side Effects

    Time frame: 6 weeks after randomization and baseline testing

    Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome.

    Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome.

Secondary outcomes

  1. Change in Self-reported Side Effects

    Time frame: 6 weeks after randomization and baseline testing

    Quality of life in Essential Tremor questionnaire (QUEST) Summary Score: A 30-item scale assessing the impact of tremor on various domains of quality of life, such as communication, work and hobbies. In the QUEST questionnaire scale, a lower score is indicative of better quality of life while higher scores indicate poorer quality of life. The score is a percentage ranging from zero to 100.

  2. Kidney Graft Survival

    Time frame: 6 months after transplant

    Number of kidney grafts still functioning at the end of the study

  3. Patient Survival

    Time frame: 6 months after transplant

    Number patients who survived during the study

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Official study title

A Pilot Study to Evaluate Impact on Neurological Side Effects (Cognition, Memory, and Tremor) in Elderly (Age>65) Patients

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2018
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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