Envarsus XR in African American Renal Transplant Recipients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

NCT04665310

Kidney Disease, End-Stage Donor Specific Antibodies Acute Rejection of Renal Transplant

ACTIVE_NOT_RECRUITING PHASE4

Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

NCT02954198

Immunosuppression

COMPLETED NA

Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

NCT04225988

Kidney Transplant Rejection

COMPLETED PHASE4

Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes

NCT04711291

Medication Adherence Renal Transplant

WITHDRAWN NA

Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

NCT03511560

Renal Transplant Rejection Kidney Transplant Failure and Rejection

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplant Recipients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

ENVARSUS®

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ENVARSUS®

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Extended Release Tacrolimus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No