NCT03321656 · Roberto Gedaly
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
What this study is about
This will be a single center, forward-looking, where both patients and doctors know the treatment given, randomly assigned, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Lexington, Kentucky
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations