Liver Transplant Rejection Clinical Trial
Official title:
Budesonide in Liver Transplantation
Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.
This study will be a randomized, open-label non-inferiority trial to assess the efficacy,
safety and tolerability of budesonide in combination with low-dose FK and standard-dose MMF
as post-OLT ISP in comparison to standard ISP (S-ISP). Subjects will include OLT patients age
18 years and older receiving their first single-organ living- or deceased-donor liver
transplant. Subjects must have post-operative recovery of graft function and be able to take
oral medications before beginning treatment according to the study protocol.
Subjects will be randomized to receive either (1) investigational oral ISP including
budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level
of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin
antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks
and assessed for adequacy of graft function, and complications of therapy, particularly ACR
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01678937 -
Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents
|
N/A | |
| Completed |
NCT03781414 -
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
|
Phase 2 | |
| Recruiting |
NCT02260375 -
MSC Therapy in Liver Transplantation
|
Phase 1 | |
| Not yet recruiting |
NCT04514666 -
VOCs in Kidney and Liver Transplants
|
N/A | |
| Not yet recruiting |
NCT05335551 -
TRU-IMMUNO: Optimizing Liver Immunosuppression
|
||
| Completed |
NCT01745731 -
Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration
|
Phase 2 | |
| Enrolling by invitation |
NCT05082077 -
Global Utilization And Registry Database for Improved preservAtion of doNor Livers
|
||
| Completed |
NCT06060808 -
Role of NFKBIA and PTPN22 Genes Polymorphism in Acute Rejection Susceptibility After Living Donor Liver Transplantation in Egyptian Patients.
|
||
| Completed |
NCT03874286 -
The TOGETHER Project - Liver
|
||
| Completed |
NCT04789213 -
Mortality, Morbidity and Risk Factors of Liver Retransplantation
|
||
| Not yet recruiting |
NCT05655273 -
Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients
|
Phase 4 | |
| Recruiting |
NCT03603548 -
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial
|
N/A | |
| Active, not recruiting |
NCT05325073 -
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
|
Phase 4 | |
| Recruiting |
NCT05707520 -
Long-term Benefit of MPA in Liver Transplantation
|
||
| Recruiting |
NCT04657562 -
The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma
|
||
| Completed |
NCT01444079 -
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
|
N/A | |
| Active, not recruiting |
NCT06153641 -
Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients
|