NCT06751992

Brief Summary

The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress9%
Mar 2026Oct 2027

First Submitted

Initial submission to the registry

December 13, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 17, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

December 13, 2024

Last Update Submit

March 17, 2026

Conditions

Kidney Transplant RecipientsOld Age

Keywords

Neurocognitive functionTacrolimusKidney transplant recipientsTremorInsomnia

Outcome Measures

Primary Outcomes (6)

  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score)

    Neurocognitive functions will be assessed across multiple cognitive domains using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3. The NIHTB-CB version 3 encompasses seven tests to assess attention, executive function, language, memory, and processing speed. The total cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.

    12 month

  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score)

    The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.

    12 month

  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score)

    The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in Standard Scores \[SS; mean of 100, standard deviation (SD) of 15\] adjusting the age of the subject. The investigators will compare the changes in standard score from baseline between the two intervention groups.

    12 month

  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score)

    The total composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The total cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.

    12 month

  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score)

    The fluid composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The fluid cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.

    12 month

  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score)

    The crystallized composite score will be obtained using the NIH toolbox-Cognitive battery (NIHTB-CB) version 3, similarly as described above. The crystallized cognition composite will be derived by averaging normalized scores. The results will be reported in T scores (mean of 50 and SD of 10) with adjustments for age, gender, education, and race/ethnicity. The investigators will compare the changes in T score from baseline between the two intervention groups.

    12 month

Secondary Outcomes (10)

  • The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)

    3 month

  • The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)

    3 month

  • The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)

    3 month

  • The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)

    3 month

  • The difference in changes of neurocognitive function in short-term (Fluid composite, T score)

    3 month

  • +5 more secondary outcomes

Other Outcomes (4)

  • Subgroup analysis of primary and secondary outcomes based on age group

    At 3 month and 12 month

  • Subgroup analysis of primary and secondary outcomes based on gender

    At 3 month and 12 month

  • Subgroup analysis of primary and secondary outcomes based on education level

    At 3 month and 12 month

  • +1 more other outcomes

Study Arms (2)

Envarsus XR conversion

EXPERIMENTAL

Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.

Drug: Conversion to extended-release tacrolimus

Prograf maintenance

ACTIVE COMPARATOR

Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.

Drug: Maintenance of immediate-release tacrolimus

Interventions

Conversion to extended-release tacrolimusDRUG

Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment

Also known as: Envarsus XR
Envarsus XR conversion
Maintenance of immediate-release tacrolimusDRUG

Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment

Also known as: Prograf
Prograf maintenance

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Able to give informed consent for participation in the study
  • Patients who have regular outpatient follow-up at the Massachusetts General Hospital (MGH) transplant center
  • ≥1 year since the latest kidney transplantation
  • On IR tacrolimus as maintenance therapy
  • At a stable therapeutic tacrolimus level (5-10 ng/ml) over the last ≥3 months
  • Stable kidney function \[\<20% variability between the last two estimated glomerular filtration rate (eGFR)\]
  • Utilizing English or Spanish as the primary language

You may not qualify if:

  • Dual organ transplantation
  • Rejection within the last three months
  • History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19)
  • History of Parkinson's disease
  • Decompensated liver disease
  • Active cancer
  • Uncontrolled depression or anxiety
  • Blindness
  • Deafness
  • Intellectual disabilities
  • Pregnancy
  • eGFR \<15 mL/min/1.73 m2 at the time of enrollment
  • Total bilirubin \>3.0 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Kidney Transplant Clinic

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

TremorSleep Initiation and Maintenance Disorders

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Leonardo V. Riella, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo V. Riella, MD, PhD

CONTACT

6177240345lriella@mgh.harvard.edu

Amelia Stocking

CONTACT

astocking@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A prospective, open-label, single-center, randomized controlled phase 4 trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Kidney Transplantation

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 30, 2024

Study Start

March 17, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

As part of our commitment to transparency and promoting further scientific research, the investigators plan to share individual participant data (IPD) from this clinical trial. The data will be made available to qualified researchers upon request, subject to appropriate data use agreements and ethical considerations. Specifically, the following data will be shared: Demographic Information: Age, sex, race. Outcomes Data: Information related to primary and secondary endpoints Adverse Events: Data on reported adverse events and serious adverse events. All data will be available in a de-identified format to protect participant confidentiality via ClinicalTrials.gov.

Shared Documents
STUDY PROTOCOL
Time Frame
The individual participant data (IPD) and supporting information will be made available to qualified researchers 6 months after the publication of the primary study results. Data will be accessible for a minimum of 5 years from the date of publication or study completion, whichever occurs later, to ensure ample time for further research and analysis.
Access Criteria
Access to individual participant data (IPD) will be granted to qualified researchers conducting non-commercial, scientifically valid research. Researchers must: 1. Submit a formal data access request, including a research proposal and ethical review approval. 2. Sign a data use agreement outlining the terms of data use, including confidentiality and non-re-identification. 3. Provide documentation of ethical approval from an Institutional Review Board or equivalent.

Locations

US(1)