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

Launched by ROBERTO GEDALY · Oct 20, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Envarsus XR® on patients with end-stage renal disease who are preparing for a kidney transplant. The goal is to see if Envarsus XR® can help reduce a specific type of kidney rejection that may not show obvious symptoms, compared to a standard medication called tacrolimus that is taken twice a day. It's important to note that the actual transplant surgery will not be part of this study.

To participate, patients need to be fluent in English and listed for a kidney transplant, and they must agree to follow the study's guidelines. Women of childbearing age will need to use two forms of birth control during the study and for a year afterward. Participants will be closely monitored throughout the trial, but there are some exclusions, including those with a history of organ transplants, certain infections, or recent cancer treatment. This trial is currently recruiting participants, and it's a great opportunity for eligible patients to contribute to important research while receiving careful medical attention.

Gender

ALL

Eligibility 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