Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Envarsus XR in African American Renal Transplant Recipients (EXR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Georgetown University

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


Condition or disease Intervention/treatment Phase
Renal Transplant Recipients Drug: ENVARSUS® Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
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
Drug: ENVARSUS®
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 Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Renal Function After Transplantation [ Time Frame: 1 year ]
    Data not collected - study terminated prematurely when PI left institution.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, District of Columbia
Medstar Georgetown Transplant Institute
Washington, District of Columbia, United States, 20005
Sponsors and Collaborators
Georgetown University
  Study Documents (Full-Text)

Documents provided by Georgetown University:
Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02956005    
Other Study ID Numbers: EXR1
First Posted: November 4, 2016    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: March 24, 2020
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action