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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roberto Gedaly
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

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