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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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| Name | Class |
|---|---|
| Veloxis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine if cognitive function improves in patients converted from tacrolimus immediate release (TAC IR) to Envarsus XR® (tacrolimus extended release) using an objective measure of cognition.
To assess cognitive function while on TAC IR and then three months after conversion to TAC XR using a traditional cognitive assessment, Montreal Cognitive Assessment (MoCA), and a broader cognitive assessment. This assessment will be used to determine if there is an objective improvement in cognitive function after conversion from TAC IR to TAC XR in kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult kidney transplant recipients | Experimental | Adult kidney transplant recipients on tacrolimus immediate release for at least six months who are being converted to tacrolimus extended release Envarsus XR® (TAC XR) for any reason by a transplant nephrologist and are willing to participate in cognitive assessment will be offered the opportunity to participate in the study. An assessment is also made at the 3 month point as baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus, Extended Release, (Envarsus Xr) | Drug | After conversion of tacrolimus immediate release to tacrolimus extended release. |
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| Measure | Description | Time Frame |
|---|---|---|
| cognitive assessment at baseline | cognitive assessment at baseline using MoCA test 7.1 | baseline |
| cognitive improvement from baseline | cognitive evaluation from baseline average for adults using NIH Toolbox Cognitive Domain | 3 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| MoCA cognitive assessment | cognitive assessment using MoCA 7.2 | 3 months after enrollment |
| NIH Toolbox cognitive test | NIH Toolbox Flanker Inhibitory Control and Attention Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Cohen, PharmD | Yale New Haven Hospital | Principal Investigator |
| Richard Formica, MD | Yale Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Transplantation Center | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| baseline |
| NIH Toolbox cognitive test | NIH Toolbox Flanker Inhibitory Control and Attention Test | 3 months |
| NIH Toolbox cognitive test | NIH Toolbox Dimensional Change Card Sort Test | baseline |
| NIH Toolbox cognitive test | NIH Toolbox Dimensional Change Card Sort Test | 3 months |
| NIH Toolbox cognitive test | NIH Toolbox Picture Sequence Memory Test Version A | baseline |
| NIH Toolbox cognitive test | NIH Toolbox Picture Sequence Memory Test Version B | 3 months |
| NIH Toolbox cognitive test | NIH Toolbox Pattern Comparison Processing Speed Test | baseline |
| NIH Toolbox cognitive test | NIH Toolbox Pattern Comparison Processing Speed Test | 3 months |
| NIH Toolbox cognitive test | NIH Toolbox List Sorting Working Memory Test | baseline |
| NIH Toolbox cognitive test | NIH Toolbox List Sorting Working Memory Test | 3 months |
| NIH Toolbox cognitive test | NIH Toolbox Reading Recognition Test | baseline |
| NIH Toolbox cognitive test | NIH Toolbox Reading Recognition Test | 3 months |