Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRoberto Gedaly
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Tacrolimus
- Envarsus XR
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Roberto Gedaly
Lead sponsor
University of Kentucky
Sponsor institution
Veloxis Pharmaceuticals
Collaborator
Source ClinicalTrials.gov