Envarsus XR in African American Renal Transplant Recipients

Renal Transplant Recipients Clinical Trial

— EXR  

Official title:

Envarsus XR in African American Renal Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02956005
• Other study ID #: EXR1
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: November 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Recipients

Intervention

Drug:
• ENVARSUS®
ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant

Locations

Country	Name	City	State
United States	Medstar Georgetown Transplant Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year
Secondary	Renal Function After Transplantation	Data not collected - study terminated prematurely when PI left institution.	1 year