Renal Transplant Recipients
Conditions
Brief summary
The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR. African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies. The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization
Interventions
DRUGENVARSUS®
ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. African American race 2. Adult renal transplant recipients (\>18 y/o) 3. Previous adverse reaction or contraindication to the use of tacrolimus
Exclusion criteria
1. Non African American race 2. Less than 18 y/o (pediatric patients) 3. Recipients of liver and small bowel transplants 4. Adverse reaction to tacrolimus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies. | 1 year | Data not collected - study terminated prematurely when PI left institution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function After Transplantation | 1 year | Data not collected - study terminated prematurely when PI left institution. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Envarsus Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not eligible | 1 |
| Overall Study | Physician Decision | 12 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Envarsus |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 0 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 13 / 18 |
| serious Total, serious adverse events | 10 / 18 |
Outcome results
Primary
Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies.
Data not collected - study terminated prematurely when PI left institution.
Time frame: 1 year
Population: Analysis not completed - PI left institution
Secondary
Renal Function After Transplantation
Data not collected - study terminated prematurely when PI left institution.
Time frame: 1 year
Population: PI left institution - Analysis not completed