Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Conversion to extended-release tacrolimus
DrugConversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Maintenance of immediate-release tacrolimus
DrugContinuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Envarsus XR conversionExperimental treatment 1 intervention
Group B: Prograf maintenanceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 month2
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.
Time frame
12 month3
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.
Time frame
12 month4
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.
Time frame
12 monthSecondary outcomes
1
The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)
Same as described above
Time frame
3 month2
The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)
Same as described above
Time frame
3 month3
The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)
Same as described above
Time frame
3 month4
The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)
Same as described above
Time frame
3 monthOther outcomes
1
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.
Time frame
At 3 month and 12 month2
Subgroup analysis of primary and secondary outcomes based on gender
The investigators will perform a subgroup analysis for each outcome based on gender to determine whether the treatment effect varies between males and females.
Time frame
At 3 month and 12 month3
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.
Time frame
At 3 month and 12 month4
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.
Time frame
At 3 month and 12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Veloxis Pharmaceuticals
Collaborator
Source ClinicalTrials.gov