Recipients of Liver Transplant Clinical Trial
Official title:
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
| Verified date | January 2021 |
| Source | Methodist Healthcare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years or older 4. Recipients of a first-time liver transplant 5. Serum Creatinine level less than 2.0 on Post-Operative Day 3-7 6. Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen 7. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration Exclusion Criteria: 1. Any prior use of tacrolimus or cyclosporine 2. Recipients of prior organ transplant 3. Need for hemodialysis in the week preceding or following liver transplantation 4. Recipients of living donor liver or split deceased donor liver allografts 5. Recipients of combined liver/kidney transplants 6. Pregnancy or lactation 7. Recipients of ABO incompatible liver allografts |
| Country | Name | City | State |
|---|---|---|---|
| United States | Methodist Healthcare, University Hospital | Memphis | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Methodist Healthcare |
United States,
Abdelmalek MF, Humar A, Stickel F, Andreone P, Pascher A, Barroso E, Neff GW, Ranjan D, Toselli LT, Gane EJ, Scarola J, Alberts RG, Maller ES, Lo CM; Sirolimus Liver Conversion Trial Study Group. Sirolimus conversion regimen versus continued calcineurin i — View Citation
Bäckman L, Nicar M, Levy M, Distant D, Eisenstein C, Renard T, Goldstein R, Husberg B, Gonwa TA, Klintmalm G. FK506 trough levels in whole blood and plasma in liver transplant recipients. Correlation with clinical events and side effects. Transplantation. — View Citation
Garnock-Jones KP. Tacrolimus prolonged release (Envarsus®): a review of its use in kidney and liver transplant recipients. Drugs. 2015 Feb;75(3):309-20. doi: 10.1007/s40265-015-0349-2. Review. — View Citation
Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. — View Citation
Kong Y, Wang D, Shang Y, Liang W, Ling X, Guo Z, He X. Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis. PLoS One. 2011;6(9):e24387. doi: 10.1371/journal.pone.0024387. Ep — View Citation
Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplan — View Citation
Niel OR, Berthoux F, Albano L, Dahan P, Aoudia R, Gugenheim J, Cassuto E. Long-term glomerular filtration rate in liver allograft recipients according to the type of calcineurin inhibitors. Transplant Proc. 2009 Oct;41(8):3329-32. doi: 10.1016/j.transproc — View Citation
Yoo MC, Vanatta JM, Modanlou KA, Campos L, Nezakatgoo N, Nair S, Eason JD. Steroid-free Liver Transplantation Using Rabbit Antithymocyte Globulin Induction in 500 Consecutive Patients. Transplantation. 2015 Jun;99(6):1231-5. doi: 10.1097/TP.00000000000004 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant | We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation. | 3, 6, and 12 months post-transplant | |
| Secondary | Quality of Life Assessment | We will be using the RAND Short Form 36 (SF36) healthcare survey to assess patient reported quality of life across a broad spectrum ranging from physical health and function to emotional well being. Each sub scale score ranges from 0 (worse) to 100 (best). | 3, 6, and 12 months post-transplant |