Liver Transplant Rejection
Conditions
Brief summary
The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.
Interventions
DRUGErythropoietin
Erythropoietin
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18-74 years * History of liver transplantation \> 2 years prior for non-immune causes * Use of immunosuppressive monotherapy (either tacrolimus or everolimus) for treatment of liver transplantation * Stable immunosuppression regimen at least 3 months prior to enrollment. * Ability to provide verbal and written informed consent
Exclusion criteria
* • Hgb above average normal value (15.7 g/dL in men, 13.8 g/dL in women); ALT \> 2 times upper limit of normal; uncontrolled hypertension with SBP\>160 or DBP\>100; end-stage renal disease on hemodialysis; history of venous thromboembolism including deep vein thromboses or pulmonary emboli, stroke, heart failure, seizure disorder, significant cardiovascular disease including a history of myocardial infarction, pure red cell aplasia, intolerance or allergy to erythropoietin; Active malignancy (untreated or undergoing therapy); known hypersensitivity to mammalian cell-derived products; known hypersensitivity to human albumin; presence of vascular access; prior recipient of erythropoietin within 12 weeks of the study; and pregnancy * Patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults. * Prisoners and other vulnerable populations will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EPO effects on Treg induction | 12 weeks | We will use flow cytometry to analyze the phenotype of peripheral blood mononuclear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lymphocyte subset frequencies, including Tregs |
Countries
United States
Outcome results
None listed