Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Northwestern University

Status and phase: Active, not recruiting; Phase 4

Conditions: Liver Transplant Rejection

Treatments: Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT05325073

STU00215838

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

EPO Arm

Other group

Treatment:

Drug: Erythropoietin