NCT03461445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 8, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

5.3 years

First QC Date

March 5, 2018

Results QC Date

August 1, 2024

Last Update Submit

April 4, 2025

Conditions

Kidney Transplant; ComplicationsToxicityDrug ToxicityNeurotoxicity

Keywords

ElderlyNeurotoxicityCalcineurin inhibitorsTacrolimus

Outcome Measures

Primary Outcomes (1)

  • Change in Neurocognitive Side Effects

    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.

    6 weeks after randomization and baseline testing

Secondary Outcomes (3)

  • Change in Self-reported Side Effects

    6 weeks after randomization and baseline testing

  • Kidney Graft Survival

    6 months after transplant

  • Patient Survival

    6 months after transplant

Study Arms (2)

Immediate Release Tacrolimus

ACTIVE COMPARATOR

Patients will receive immediate release tacrolimus

Drug: IR Tacrolimus

Envarsus

EXPERIMENTAL

Patients will be converted to Envarsus formulation of tacrolimus

Drug: Envarsus

Interventions

EnvarsusDRUG

Patients will be randomized to receiving Envarsus instead of IR Tacrolimus

Envarsus
IR TacrolimusDRUG

Patients will be randomized to receiving IR Tacrolimus instead of Envarsus

Immediate Release Tacrolimus

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Related Links

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsNeurotoxicity Syndromes

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersNervous System DiseasesPoisoning

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Associate Professor of Medicine
Organization
UC Davis Health
lxchen@ucdavis.edu
916-734-5141

Study Officials

  • Ling-Xin Chen, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 12, 2018

Study Start

April 1, 2018

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

April 8, 2025

Results First Posted

April 8, 2025

Record last verified: 2025-04

Locations

US(1)