NCT03321656RecruitingPhase 2/3
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 28 Sept 2017
- Start date
- 28 Mar 2019
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Roberto Gedaly
- Diseases
- Chronic kidney disease
- NCT number
- NCT03321656
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 78
- From 28 Mar 2019 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously undergone organ, tissue or cell transplant
- Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
- Have taken part in another study that involved an investigational drug within the last 12 months.
- Current use anticoagulation medication
Other illness
- Allergic to Tacrolimus or MMF (Cellcept)
- 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 a history of delayed or abnormal wound healing
Other
- Chronic use of blood thinners
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Deepa Valvi Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.