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NCT06751992 · ClinicalTrials.gov registry record · Phase 4
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
A Phase 4 study of Kidney Transplant Recipients and Old Age, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT06751992: Recruiting Phase 4 study of Kidney Transplant Recipients and Old Age, sponsored by Massachusetts General Hospital.
NCT06751992 is a Phase 4 study of Kidney Transplant Recipients and Old Age that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 92 participants, above the 55-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (67% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06751992, a Phase 4 study of Kidney Transplant Recipients and Old Age, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Conversion to extended-release tacrolimus
- DRUG Maintenance of immediate-release tacrolimus
Study Locations (1)
Massachusetts
- MGH Kidney Transplant Clinic - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-03-17 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 4 |
What NCT06751992 shows while recruiting
NCT06751992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 55-participant average among 4 other Kidney Transplant Recipients trials with a reported enrollment target (67% higher).
The record links to 2 conditions, with Kidney Transplant Recipients appearing as the primary indexed condition, and to 2 interventions - of which Conversion to extended-release tacrolimus is the first listed.
NCT06751992 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06751992 about?
NCT06751992 is a clinical study titled "Neurocognitive Function Changes With Extended-Release Tacrolimus 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).
What is the current status of trial NCT06751992?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 92 participants. The study started on 2026-03-17. Estimated completion is 2027-10-01.
What conditions does trial NCT06751992 study?
This clinical trial studies the following conditions: Kidney Transplant Recipients, Old Age.
What interventions are being tested in trial NCT06751992?
The interventions under investigation include: Conversion to extended-release tacrolimus (DRUG), Maintenance of immediate-release tacrolimus (DRUG).
Who is sponsoring clinical trial NCT06751992?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06751992 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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