What this study is
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.
What's being tested
- Tacrolimus
Intervention · DRUG
0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
- Envarsus XR
Intervention · DRUG
0.07-0.14 mg/kg/day every morning orally
Study details
- Sponsor
- Roberto Gedaly
- Conditions
- End Stage Renal Disease
- Enrolling
- 78 people
- Starts
- 2019-03-28
- Est. completion
- 2027-03-31
- Design
- Open-label, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDeepa Valvi
Lexington, Kentucky, United States
- Deepa Valvi, DrPH · Contact8592579443deepa.valvi@uky.edu
- Roberto Gedaly, MD · Principal investigator
- TrisAnn Rendulic, PharmD · Sub-investigator
Recruiting
Study team
Sponsor
Roberto Gedaly
Study ID 42753
Principal investigator
Roberto Gedaly, MD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.