Envarsus XR in African American Renal Transplant Recipients

Not Applicable

Terminated

• Conditions: Renal Transplant Recipients
• Interventions: Drug: ENVARSUS®

• Registration Number: NCT02956005
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Results First Submitted: 2019-08-14
• Results First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Results First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Envarsus	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Renal Function After Transplantation	1 year	Data not collected - study terminated prematurely when PI left institution.

Trial Locations

Locations (1)

Medstar Georgetown Transplant Institute; 🇺🇸 Washington, District of Columbia, United States