Envarsus XR in African American Renal Transplant Recipients

NCT02956005 | Terminated Results

• 1 other identifier: EXR1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Renal Function After Transplantation

  1 year

Study Arms (1)

Envarsus

OTHER

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®

Interventions

ENVARSUS® DRUG

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

Also known as: Extended Release Tacrolimus

Envarsus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American race
• Adult renal transplant recipients (\>18 y/o)
• Previous adverse reaction or contraindication to the use of tacrolimus

You may not qualify if:

• Non African American race
• Less than 18 y/o (pediatric patients)
• Recipients of liver and small bowel transplants
• Adverse reaction to tacrolimus

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Medstar Georgetown Transplant Institute

Washington D.C., District of Columbia, 20005, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

The PI of this study left the institution before the study was completed. Patients were followed until the completion of the study if applicable, but no study data analysis was performed.

Results Point of Contact

• Title: Alexander Gilbert
• Organization: MedStar Georgetown Transplant Institute

Alexander.J.Gilbert@gunet.georgetown.edu

202-444-0621

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2016-11

Locations

US (1)