Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

STU00215838

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.

2022-02-18

2023-05-23

2024-09-30

Active (not recruiting)

Early phase I

9

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

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2024-03-15