Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Veloxis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related toxicities. Therefore, the investigators hypothesize that by transitioning patients from tacrolimus immediate release to Envarsus ®, the peak-dose effect will be eliminated or attenuated, leading to a significant decrease in neurocognitive toxicities in the older patient population.
The investigators will conduct a single-center, prospective, open-label, randomized study to evaluate the difference in neurocognitive side effects between Envarsus and immediate release tacrolimus. Eligible patients will be enrolled within 8 weeks post-transplantation. They will be administered a baseline panel of neurocognitive tests. They will then be randomized to either continue on immediate release tacrolimus or Envarsus. 6 weeks after randomization, the neurocognitive tests will be repeated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Release Tacrolimus | Active Comparator | Patients will receive immediate release tacrolimus |
|
| Envarsus | Experimental | Patients will be converted to Envarsus formulation of tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envarsus | Drug | Patients will be randomized to receiving Envarsus instead of IR Tacrolimus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurocognitive Side Effects | Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome. | 6 weeks after randomization and baseline testing |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Side Effects | Quality of life in Essential Tremor questionnaire (QUEST) Summary Score: A 30-item scale assessing the impact of tremor on various domains of quality of life, such as communication, work and hobbies. In the QUEST questionnaire scale, a lower score is indicative of better quality of life while higher scores indicate poorer quality of life. The score is a percentage ranging from zero to 100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ling-Xin Chen, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States |
Not provided
| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Release Tacrolimus | Patients will receive immediate release tacrolimus IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus |
| FG001 | Envarsus | Patients will be converted to Envarsus formulation of tacrolimus Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Release Tacrolimus | Patients will receive immediate release tacrolimus IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus |
| BG001 | Envarsus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neurocognitive Side Effects | Change in MOCA (Montreal Cognitive Assessment) from baseline to study end. MOCA scale runs from 0 to 30 with higher being a better outcome. Change in DSST (Digital Symbol Substitution Test) from baseline to study end. DSST scale runs from 1 to 125 with higher being a better outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after randomization and baseline testing |
|
While participants were enrolled in the study (6 week period for each individual).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Release Tacrolimus | Patients will receive immediate release tacrolimus IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cognitive decline | Nervous system disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor of Medicine | UC Davis Health | 916-734-5141 | lxchen@ucdavis.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2018 | Jan 6, 2025 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IR Tacrolimus |
| Drug |
Patients will be randomized to receiving IR Tacrolimus instead of Envarsus |
|
| 6 weeks after randomization and baseline testing |
| Kidney Graft Survival | Number of kidney grafts still functioning at the end of the study | 6 months after transplant |
| Patient Survival | Number patients who survived during the study | 6 months after transplant |
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Change in Self-reported Side Effects | Quality of life in Essential Tremor questionnaire (QUEST) Summary Score: A 30-item scale assessing the impact of tremor on various domains of quality of life, such as communication, work and hobbies. In the QUEST questionnaire scale, a lower score is indicative of better quality of life while higher scores indicate poorer quality of life. The score is a percentage ranging from zero to 100. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after randomization and baseline testing |
|
|
|
| Secondary | Kidney Graft Survival | Number of kidney grafts still functioning at the end of the study | Posted | Number | kidney grafts | 6 months after transplant |
|
|
|
| Secondary | Patient Survival | Number patients who survived during the study | Posted | Count of Participants | Participants | 6 months after transplant |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Envarsus | Patients will be converted to Envarsus formulation of tacrolimus Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus | 0 | 32 | 2 | 32 | 0 | 32 |
| Medication Overdose | Immune system disorders | Non-systematic Assessment |
|
Not provided