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| Name | Class |
|---|---|
| Veloxis Pharmaceuticals | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversion to extended-release tacrolimus | Drug | Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score) | Same as described above | 3 month |
| The difference in changes of neurocognitive function in short-term (Fluid composite, standard score) |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analysis of primary and secondary outcomes based on age group | The investigators will analyze the differential impact of the intervention in participants aged 75 years and older, compared to those under 75 years old. | At 3 month and 12 month |
| Subgroup analysis of primary and secondary outcomes based on gender |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo V. Riella, MD, PhD | Contact | 6177240345 | 40345 | lriella@mgh.harvard.edu |
| Amelia Stocking | Contact | 617-724-1976 | astocking@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leonardo V. Riella, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Kidney Transplant Clinic | Recruiting | Boston | Massachusetts | 02114 | United States |
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.
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 to individual participant data (IPD) will be granted to qualified researchers conducting non-commercial, scientifically valid research. Researchers must:
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A prospective, open-label, single-center, randomized controlled phase 4 trial
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| Maintenance of immediate-release tacrolimus | Drug | Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment |
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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 |
Same as described above
| 3 month |
| The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score) | Same as described above | 3 month |
| The difference in changes of neurocognitive function in short-term (Total cognition composite, T score) | Same as described above | 3 month |
| The difference in changes of neurocognitive function in short-term (Fluid composite, T score) | Same as described above | 3 month |
| The difference in changes of neurocognitive function in short-term (Crystallized composite, T score) | Same as described above | 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. | 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. | 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. | 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. | 3 month and 12 month |
The investigators will perform a subgroup analysis for each outcome based on gender to determine whether the treatment effect varies between males and females. |
| At 3 month and 12 month |
| Subgroup analysis of primary and secondary outcomes based on education level | The investigators will analyze the differential impact of the intervention in participants with Bachelor's degree holders, compared to those without Bachelor's degree holders. | At 3 month and 12 month |
| Subgroup analysis of primary and secondary outcomes based on the baseline cognitive function | The investigators will perform a subgroup analysis for each outcome based on baseline cognitive function to determine whether the treatment effect varies according to baseline cognitive function. Participants with a baseline NIHTB-CB total composite T score ≤ 43 (corresponding to the lower 25th percentile adjusted for age, gender, education, and race/ethnicity) will be separately analyzed to those with a score > 43. | At 3 month and 12 month |
| ID | Term |
|---|---|
| D014202 | Tremor |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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