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
Qualifiers
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
Treatments tested in this trial
- Conversion to extended-release tacrolimus
- Maintenance of immediate-release tacrolimus
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Veloxis Pharmaceuticals
Collaborator
Source ClinicalTrials.gov