Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Roberto Gedaly

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Tacrolimus; Drug: Envarsus XR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03321656

42753

Details and patient eligibility

About

This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.

Full description

Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements.

The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required.

All participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to Envarsus vs. Tacrolimus at the time of transplant.

Participants will be randomized to one of two treatment arms. Treatment begins on post-op day 1.

• Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning
• Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours

The total amount of time a person will be asked to volunteer for this study is 9-18 hours over the next 6 months.

Participants will need to complete 9 study visits each of these visits will take approximately 1-2 hours to complete. Participants will be given medication dosing diaries to complete throughout the study and will undergo 2 kidney biopsies.

Participants will be screened for HIV, Hepatitis B and Hepatitis C viruses.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fluent in English able to understand and provide informed consent.
• End stage renal disease listed for primary solitary kidney transplant.
• Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
• Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.

Exclusion criteria

• Previously undergone organ, tissue or cell transplant
• Allergic to Tacrolimus or MMF (Cellcept)
• Chronic use of blood thinners
• Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
• Significant or active infection
• Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
• Have or have had cancer with in the past 3 years
• Have taken part in another study that involved an investigational drug within the last 12 months.
• Have a history of delayed or abnormal wound healing
• Are pregnant or breastfeeding
• Had a transfusion within the past 3 months
• Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
• Are unable or unwilling to comply with study protocol or procedures.
• Current use anticoagulation medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally

Treatment:

Drug: Tacrolimus

Envarsus XR

Experimental group

Description:

0.07-0.14 mg/kg/day every morning orally

Treatment:

Drug: Envarsus XR