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Renal TransplantPhase 4OPERATORNCT04838288

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

A Phase 4 study testing Change from Prograf to Envarsus XR in people with Renal Transplant, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Transplant
What is being tested?
Change from Prograf to Envarsus XR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
22 Jun 2021to 22 Oct 2025
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 27Show fewer
  • 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;
  • Patients with acute or chronic depression, corresponding to a score of ≥20 (corresponding to moderate depression) on the BDI-II at screening;
  • Patients who are taking any acute or chronic medications that may impact reaction time, memory, or sleep habits, based on Investigator discretion;
  • Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed release tablets (Myfortic), or generic versions of these medications, as per SOC, who have not been on stable doses (i.e., no dose adjustments or formulation change) for at least 4-7 days prior to screening;
  • Patients receiving prednisone or equivalent >10 mg/day;
  • Patients with an episode of biopsy-proven or suspected acute rejection that requires treatment within 3 months of screening;
  • Patients who are being actively treated for cancer (with the exception of non-invasive basal cell or cutaneous squamous cell carcinoma);
  • Patients known to be human immunodeficiency virus (HIV) positive;
  • Patients with any form of current drug or alcohol abuse as assessed by the Investigator;
  • Patients who were treated with any other investigational agent within 1 month prior to screening;
  • Pregnant or nursing women or women planning to become pregnant, where pregnancy is defined as a state of the female patient after conception and until the termination of gestation, confirmed by a positive urine laboratory test; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC birth control method; UNLESS they are:
  • Women whose career, lifestyle, or sexual orientation preclude intercourse with a partner
  • Women whose partners have been sterilized by medically approved means

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VUMC

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Cognitive Outcomes and Quality of Life in Stable Renal Transplant Patients Switched fromTwice-Daily Tacrolimus to Envarsus XR™

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.

Read the detailed description

Patients with chronic kidney disease most commonly show cognitive impairments involving attention, memory, executive functions, and mental processing speed. Although data have demonstrated improvements in cognition following kidney transplant and the reversibility of the memory problems evidenced in dialysis, neurotoxicity in transplant patients occurs in >40-50% of the patients treated with tacrolimus. Attention and working memory impairment have been observed in patients treated with sirolimus or tacrolimus, while cyclosporine-treated patients demonstrated performance similar to that of healthy volunteer controls, which may indicate that the cognitive deficit found was partly related to treatment. ENVARSUS XR is a new FDA-approved formulation of tacrolimus. A hallmark difference between ENVARSUS XR and other forms of once- and twice-daily tacrolimus products is the unique, proprietary MeltDose® drug delivery technology (Veloxis Pharmaceuticals, Hørsholm, Denmark) which reduces tacrolimus' particle size to a molecular level. The decreased surface area of the drug particles results in complete absorption and increased bioavailability in a once-daily dosing formulation. In stable kidney transplant patients, ENVARSUS XR pharmacokinetics are characterized by a steadier and more consistent concentration time profile over 24 hours, reduced peak and peak-to-trough fluctuations and similar exposure while benefiting from ~ 20% less total daily dose than twice daily tacrolimus. This open-label, prospective phase clinical trial is designed to evaluate whether switching patients from TAC-IR to ENVARSUS XR treatment improves cognitive function.

Being tested
Change from Prograf to Envarsus XR
Keywords
cognitive function, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Change from Prograf to Envarsus XRDrug

    Also called Change from Tacrolimus to Envarsus XR

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

Study groups in NCT04838288
Study groupRoleWhat they receive
Change from Prograf to EnvarsusExperimentalAll participants will be switched from Prograf to Envarsus
Receives: Drug: Change from Prograf to Envarsus XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to month 4

  2. 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.

    Measured: Baseline to month 4

Secondary outcomes (6)

  1. Change in Cognitive Function on Trail Making Part A

    Measured by Trail Making Part A. Maximum time given for TMT A is 150 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

    Measured: Baseline to month 4

  2. Change in Cognitive Function on Trail Making Part B

    Measured by Trail Making Part B. Maximum time given for TMT B is 300 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.

    Measured: Baseline to month 4

  3. Change in Quality of Life

    Change in quality of life measured by WHODAS. The total score of WHODAS is the sum of all the 12 sub-scores and ranges from 0 to 48, with lower scores indicating better functioning. Total scores of 1-4 belong to mild disability, 5-9 to moderate disability, and 10-48 to severe disability

    Measured: Baseline to Month 4

  4. Impression of Improvement by PGI

    measured by PGI-I (Patient's Global Impression of Improvement). The PGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much better (1) to very much worse (7)

    Measured: baseline to month 4

  5. Impression of Improvement by CGI

    measured by CGI-I (Clinical Global Impression of Improvement). The CGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much improved (1) to very much worse (7).

    Measured: baseline to month 4

  6. Change of Quality of Sleep

    measured by PIRS-20 (Pittsburgh Insomnia Rating Scale). The PIRS-20 total score is the sum of all items and ranges from 0 (good sleep) to 60 (bad sleep).3

    Measured: Baseline to month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2021
  2. Study start22 Jun 2021
  3. Primary completion1 Jan 2025
  4. Study completion22 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838288
Sponsor's protocol ID
201108
Acronym
OPERATOR
Status last verified
Nov 2025
First submitted
31 Mar 2021
Last updated
29 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Change from Prograf to Envarsus XR in people with Renal Transplant, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Function-Global on Covid-19 Telephone Battery (time frame: Baseline to month 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838288.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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