Envarsus XR in African American Renal Transplant Recipients (EXR)
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|ClinicalTrials.gov Identifier: NCT02956005|
Recruitment Status : Terminated (IIS - PI left the institution. Subjects just followed to study completion)
First Posted : November 4, 2016
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant Recipients||Drug: ENVARSUS®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Envarsus XR in African American Renal Transplant Recipients|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
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 XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
Other Name: Extended Release Tacrolimus
- Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies. [ Time Frame: 1 year ]Data not collected - study terminated prematurely when PI left institution.
- Renal Function After Transplantation [ Time Frame: 1 year ]Data not collected - study terminated prematurely when PI left institution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956005
|United States, District of Columbia|
|Medstar Georgetown Transplant Institute|
|Washington, District of Columbia, United States, 20005|