💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
Deepa Valvi
Lexington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky