Trials / Completed
CompletedNCT03828058
Envarsus XL Immunosuppression Following Liver Transplantation
A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Methodist Healthcare · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Envarsus XR | Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels. |
| DRUG | Prograf | Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels. |
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2019-02-04
- Last updated
- 2021-01-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03828058. Inclusion in this directory is not an endorsement.