Overview

Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Status:
Recruiting
Trial end date:
2023-06-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Treatments:
Epoetin Alfa
Criteria
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