Trial Outcomes & Findings for CNS Study of Patients Switching From Tacrolimus to Envarsus (NCT NCT03270462)

Last Updated: 2022-06-02

Results Overview

The Investigators will evaluate the quality of life between baseline and 6 months related to sleep disturbance and upper extremity fine motor skills/ADL (activities of daily living), with the goal to be an improvement in their quality of life. This was assessed via a study-specific clinical assessment that evaluated patient reports of hand tremor and related complaints, and scored in a range of 0 to 3, with higher scores indicating worse symptoms of hand tremor, and a lower QOL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 1 Month, 6 Months

Results posted on

2022-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Envarsus XR A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CNS Study of Patients Switching From Tacrolimus to Envarsus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Envarsus XR n=20 Participants A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 Month, 6 Months

Outcome measures

Outcome measures
Measure	Envarsus XR n=20 Participants A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Change in Quality of Life Baseline	2.7 score on a scale Interval 2.0 to 3.0
Change in Quality of Life Month 1	1.35 score on a scale Interval 0.0 to 2.0
Change in Quality of Life Month 6	0.2 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, 1 Month, 6 Months

The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.

Outcome measures

Outcome measures
Measure	Envarsus XR n=20 Participants A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Therapeutic Tacrolimus Drug Levels Baseline	8.66 ng/ml Standard Deviation 2.71
Therapeutic Tacrolimus Drug Levels Month 1	8.58 ng/ml Standard Deviation 1.75
Therapeutic Tacrolimus Drug Levels Month 6	8.48 ng/ml Standard Deviation 2.43

SECONDARY outcome

Timeframe: Baseline, 1 Month, 6 Months

The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.

Outcome measures

Outcome measures
Measure	Envarsus XR n=20 Participants A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. Envarsus XR: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Kidney Function: Serum Creatinine Levels Baseline	1.19 mg/dl Standard Deviation 0.31
Kidney Function: Serum Creatinine Levels Month 1	1.14 mg/dl Standard Deviation 0.34
Kidney Function: Serum Creatinine Levels Month 6	1.11 mg/dl Standard Deviation 0.35

Adverse Events

Envarsus XR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry Chan

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place