Trial Outcomes & Findings for Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients (NCT NCT03461445)
NCT ID: NCT03461445
Last Updated: 2025-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
6 weeks after randomization and baseline testing
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
Immediate Release Tacrolimus
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Immediate Release Tacrolimus
n=32 Participants
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=32 Participants
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
69 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
69 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown/Other
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / Pacific Islander
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after randomization and baseline testingChange 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.
Outcome measures
| Measure |
Immediate Release Tacrolimus
n=31 Participants
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=31 Participants
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Change in Neurocognitive Side Effects
MOCA score difference
|
1.2 score on a scale
Standard Deviation 2.1
|
0.2 score on a scale
Standard Deviation 2.9
|
|
Change in Neurocognitive Side Effects
DSST score difference
|
1.0 score on a scale
Standard Deviation 7.8
|
1.26 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 6 weeks after randomization and baseline testingQuality 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.
Outcome measures
| Measure |
Immediate Release Tacrolimus
n=32 Participants
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=32 Participants
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Change in Self-reported Side Effects
|
-1.2 score on a scale
Standard Deviation 7.5
|
-3.1 score on a scale
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 6 months after transplantNumber of kidney grafts still functioning at the end of the study
Outcome measures
| Measure |
Immediate Release Tacrolimus
n=32 Participants
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=32 Participants
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Kidney Graft Survival
|
32 kidney grafts
|
32 kidney grafts
|
SECONDARY outcome
Timeframe: 6 months after transplantNumber patients who survived during the study
Outcome measures
| Measure |
Immediate Release Tacrolimus
n=32 Participants
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=32 Participants
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Patient Survival
|
32 Participants
|
32 Participants
|
Adverse Events
Immediate Release Tacrolimus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Envarsus
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Release Tacrolimus
n=32 participants at risk
Patients will receive immediate release tacrolimus
IR Tacrolimus: Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
|
Envarsus
n=32 participants at risk
Patients will be converted to Envarsus formulation of tacrolimus
Envarsus: Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
|
|---|---|---|
|
Nervous system disorders
Cognitive decline
|
0.00%
0/32 • While participants were enrolled in the study (6 week period for each individual).
|
3.1%
1/32 • Number of events 1 • While participants were enrolled in the study (6 week period for each individual).
|
|
Immune system disorders
Medication Overdose
|
0.00%
0/32 • While participants were enrolled in the study (6 week period for each individual).
|
3.1%
1/32 • Number of events 1 • While participants were enrolled in the study (6 week period for each individual).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60