Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    20
  • sponsor
    Northwestern University
Updated on 2 May 2022

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.

Details
Condition Liver Transplant Rejection
Treatment erythropoietin
Clinical Study IdentifierNCT05325073
SponsorNorthwestern University
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

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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