Renal Transplant Patients
Conditions
Brief summary
This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation. A standardized questionnaire will be used to document these symptoms.
Detailed description
Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. This study provides renal transplant patients the opportunity for an alternative treatment using tacrolimus, with possible less Central Nervous Symptom (CNS) side effects. CNS side effects are one of the main reasons that patients complain about after having a kidney transplant while on tacrolimus (Prograf). The side effects can be debilitating and can affect the patient's overall well-being. In severe cases it may lead to non-compliance. The advantage of the study of using Envarsus is the ability to avoid these debilitating CNS side effects and afford better compliance with the patients taking the medicine.
Interventions
DRUGEnvarsus 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Kidney transplant recipients with stable graft function. * More than 1 months post-transplant. * 18+ years of age with some CNS problems secondary to Prograf (tacrolimus).
Exclusion criteria
* Multi-organ patients (kidney/pancreas, kidney/liver). * Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit. * Inability to self-administer the QOL questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline, 1 Month, 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Tacrolimus Drug Levels | Baseline, 1 Month, 6 Months | The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure. |
| Kidney Function: Serum Creatinine Levels | Baseline, 1 Month, 6 Months | The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Envarsus XR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Quality of Life
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.
Time frame: Baseline, 1 Month, 6 Months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Envarsus XR | Change in Quality of Life | Baseline | 2.7 score on a scale |
| Envarsus XR | Change in Quality of Life | Month 1 | 1.35 score on a scale |
| Envarsus XR | Change in Quality of Life | Month 6 | 0.2 score on a scale |
Secondary
Kidney Function: Serum Creatinine Levels
The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.
Time frame: Baseline, 1 Month, 6 Months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Envarsus XR | Kidney Function: Serum Creatinine Levels | Month 1 | 1.14 mg/dl | Standard Deviation 0.34 |
| Envarsus XR | Kidney Function: Serum Creatinine Levels | Month 6 | 1.11 mg/dl | Standard Deviation 0.35 |
| Envarsus XR | Kidney Function: Serum Creatinine Levels | Baseline | 1.19 mg/dl | Standard Deviation 0.31 |
Secondary
Therapeutic Tacrolimus Drug Levels
The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.
Time frame: Baseline, 1 Month, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Envarsus XR | Therapeutic Tacrolimus Drug Levels | Baseline | 8.66 ng/ml | Standard Deviation 2.71 |
| Envarsus XR | Therapeutic Tacrolimus Drug Levels | Month 1 | 8.58 ng/ml | Standard Deviation 1.75 |
| Envarsus XR | Therapeutic Tacrolimus Drug Levels | Month 6 | 8.48 ng/ml | Standard Deviation 2.43 |