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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02956005
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Monica Grafals, MD, MPD, 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Open Label
ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant

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 ]

Secondary Outcome Measures :
  1. Renal function after transplantation [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

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 identifier (NCT number): NCT02956005

United States, District of Columbia
Medstar Georgetown Transplant Institute Recruiting
Washington, District of Columbia, United States, 20005
Contact: Monica Grafals, MD, MPH    202-444-3700      
Sponsors and Collaborators
Georgetown University

Responsible Party: Monica Grafals, MD, MPD, Transplant Nephrologist, Georgetown University Identifier: NCT02956005     History of Changes
Other Study ID Numbers: EXR1
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action