Kidney Transplant RecipientsPhase 4Neuro-KTRNCT06751992
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
A Phase 4 study testing Conversion to extended-release tacrolimus and Maintenance of immediate-release tacrolimus in people with Kidney Transplant Recipients and Old Age, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Kidney Transplant Recipients, Old Age
- What is being tested?
- Conversion to extended-release tacrolimus and Maintenance of immediate-release tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH Kidney Transplant Clinic
Boston, Massachusetts, 02114
Riella, M.D., Ph.D., 877-644-2860, lriella@mgh.harvard.edu
About this study
Official title: Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
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).
- Conditions
- Kidney Transplant Recipients, Old Age
- Being tested
- Conversion to extended-release tacrolimus, Maintenance of immediate-release tacrolimus
- Keywords
- Neurocognitive function, Tacrolimus, Kidney transplant recipients, Tremor, Insomnia
- Medical subject headings
- Tremor, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to extended-release tacrolimusDrug
Also called Envarsus XR
Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Maintenance of immediate-release tacrolimusDrug
Also called Prograf
Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Maintenance of immediate-release tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month
Secondary outcomes (10)
The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)
Same as described above
Measured: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)
Same as described above
Measured: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)
Same as described above
Measured: 3 month
The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)
Same as described above
Measured: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, T score)
Same as described above
Measured: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, T score)
Same as described above
Measured: 3 month
The changes in quality of life, measured by SONG-LP questionnaire
The Standardized Outcome in Nephrology-Life Participation (SONG-LP) questionnaire will evaluate each participant's engagement in significant life domains in correlation with the intervention. This questionnaire assesses life participation in the areas of leisure, family, work, and social activities through four simple questions. The score ranges from 4 to 20, with a higher score indicating greater engagement in life activities. The difference in changes of total score from baseline between the two intervention groups will be obtained.
Measured: 3 month and 12 month
The changes in tremor, measured by QUEST questionnaire
Quality of Life in Essential Tremor (QUEST) questionnaire will be used to assess tremors subjectively. This questionnaire comprises 30 items contributing to the five dimensions: physical/activities of daily living, psychosocial, communication, hobbies/leisure, and work/finances. The investigators will also obtain self-rated tremor severity in various body parts. The score ranges from 0 to 120, with a higher score indicating a greater impact on their QOL from tremor. The investigators will compare the changes in total score and the score on each scale from baseline between the two intervention groups.
Measured: 3 month and 12 month
The changes in sleep quantity, measured by a wearable device
The investigators will assess each participant's sleep quantity using wearable devices. The participants will be instructed to wear the device continuously for 14 days at pre-specified time points during the study period. Sleep quantity will be represented by the total amount of time spent asleep. The difference in changes in sleep quantity from baseline will be compared between the two intervention groups.
Measured: 3 month and 12 month
The changes in sleep quality, measured by a wearable device
The investigators will objectively assess each participant's sleep quality using wearable devices. The participants will be instructed to wear the device continuously for 14 days at pre-specified time points during the study period. Sleep quality will be measured as a percentage of time spent in deep sleep and REM sleep to the total sleep time. A higher percentage indicates a better sleep quality. The changes in sleep quality from baseline will be compared between the two intervention groups.
Measured: 3 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start17 Mar 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, open-label, single-center, randomized controlled phase 4 trial
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Principal investigator, Leonardo V. Riella, MD, PhD, Massachusetts General Hospital
- Investigators
- Leonardo V. Riella, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751992
- Sponsor's protocol ID
- 2024P000460
- Acronym
- Neuro-KTR
- Status last verified
- Mar 2026
- First submitted
- 13 Dec 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06751992
- Acronym / sponsor ID
- Neuro-KTR / 2024P000460
- Conditions
- Kidney Transplant Recipients, Old Age
- Keywords
- Neurocognitive function, Tacrolimus, Kidney transplant recipients, Tremor, Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, open-label, single-center, randomized controlled phase 4 trial
| Arm | Type | Receives |
|---|---|---|
| Envarsus XR conversion | Experimental | Drug: Conversion to extended-release tacrolimusPatients 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. |
| Prograf maintenance | Active comparator | Drug: Maintenance of immediate-release tacrolimusPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversion to extended-release tacrolimusAlso: Envarsus XRConversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment | Drug | Envarsus XR conversion |
| Maintenance of immediate-release tacrolimusAlso: PrografContinuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment | Drug | Prograf maintenance |
Primary outcome
The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score)
Time frame: 12 month
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.
The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score)
Time frame: 12 month
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.
The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score)
Time frame: 12 month
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.
The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score)
Time frame: 12 month
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.
The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score)
Time frame: 12 month
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.
The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score)
Time frame: 12 month
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.
10 secondary outcomes
The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Fluid composite, T score)
Time frame: 3 month
The difference in changes of neurocognitive function in short-term (Crystallized composite, T score)
Time frame: 3 month
The changes in quality of life, measured by SONG-LP questionnaire
Time frame: 3 month and 12 month
The changes in tremor, measured by QUEST questionnaire
Time frame: 3 month and 12 month
The changes in sleep quantity, measured by a wearable device
Time frame: 3 month and 12 month
The changes in sleep quality, measured by a wearable device
Time frame: 3 month and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo V. Riella, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conversion to extended-release tacrolimus and Maintenance of immediate-release tacrolimus in people with Kidney Transplant Recipients and Old Age, run by Massachusetts General Hospital 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonardo V. Riella, MD, PhD (6177240345 ext. 40345, lriella@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score) (time frame: 12 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.