Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™

NCT04838288 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201108
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function.

Conditions

Renal Transplant

Keywords

cognitive function; Quality of life

Outcome Measures

Primary Outcomes (2)

• Change in Cognitive Function-Global on Covid-19 Telephone Battery

  Due to safety precautions for COVID-19 precluding us from seeing patients in person, neurocognitive function was assessed via a phone battery derived from standard cognitive tests and proven feasible and valid to assess memory, attention, reasoning, and executive function, including TICS (Telephone interview for Cognitive Testing: Scale of 0-41, \<26= mild cognitive impairment), WAIS-IV (Digit Span and Similarities: Scale of 1-19, \<=6 impairment), WMS-IV (Logical Memory Subsets I \& II: Scale of 1-19, \<=6 impairment), Controlled Oral Word Association (COWA: Scale of 0-53, \<=35 impairment), and Hayling Sentence Completion (Scale of 1-10, \<= 3.7 impairment).

  Baseline to month 4

• Change in Cognitive Function-Global on RBANS

  Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Scores range from 40-160, with 160 referring to higher cognitive functioning.

  Baseline to month 4

Secondary Outcomes (6)

• Change in Cognitive Function on Trail Making Part A

  Baseline to month 4

• Change in Cognitive Function on Trail Making Part B

  Baseline to month 4

• Change in Quality of Life

  Baseline to Month 4

• Impression of Improvement by PGI

  baseline to month 4

• Impression of Improvement by CGI

  baseline to month 4

Study Arms (1)

Change from Prograf to Envarsus

EXPERIMENTAL

All participants will be switched from Prograf to Envarsus

Drug: Change from Prograf to Envarsus XR

Interventions

Change from Prograf to Envarsus XR DRUG

Change from Tacrolimus taken twice a day to Envarsus XR taken once a day

Also known as: Change from Tacrolimus to Envarsus XR

Change from Prograf to Envarsus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to understand English and provide written informed consent;
• Males and females between 18 and 70 years of age;
• Recipients of a primary or secondary kidney transplant 4 weeks to 10 years prior to screening;
• Patients receiving a stable dose (i.e., no dose adjustments) of TAC-IR for a minimum of 4-7 days at screening;
• Patients with a screening TAC-IR trough level of 3-9 ng/mL, measured between Day -7 to 0;
• Women of childbearing potential must have a negative urine pregnancy test at screening;
• Patients must be willing to commit to and comply with the schedule of study visits.
• The patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit and pomegranate products), or medications listed in Appendix 1.

You may not qualify if:

• Recipients of any transplanted organ other than kidney;
• Patients with an estimated glomerular filtration rate (eGFR) (MDRD4) \< 25 mL/min at screening;
• Patients with significant visual impairments affecting their ability to complete the study requirements and assessments: patient's vision is 20/200 or worse;
• Patients with significant hearing impairments affecting their ability to complete the study requirements and assessments, based on Investigator discretion;
• Patients with any severe medical condition (including infection) requiring acute or chronic treatment that in the Investigator's opinion would interfere with study participation;
• Patients who have a history of any of the following, based on documentation of clinical conditions and concomitant medications in the medical records:
• Cognitive decline secondary to stroke, per Investigator discretion
• Dementia
• Resected or existing brain tumor
• Acute or chronic bipolar psychosis or schizophrenia per Investigator discretion
• Mental retardation
• Moderate or severe traumatic brain injury
• Failure of any major organ other than the kidneys (e.g., end-stage liver disease)
• Known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the Investigator's opinion would interfere with the objectives of the study
• Patients with medical history of hypertension or diabetes which is unmanageable by medically approved intervention (e.g., medication/diet) as assessed by the Investigator;

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

VUMC

Nashville, Tennessee, 37232, United States

Location

Results Point of Contact

• Title: Anthony Langone, MD
• Organization: Vanderbilt University Medical Center

ctgov@vumc.org

615-936-1179

Study Officials

• Anthony Langone, MD

  VUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 9, 2021
• Study Start: June 22, 2021
• Primary Completion: January 1, 2025
• Study Completion: October 22, 2025
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)