Status:
ACTIVE_NOT_RECRUITING
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
Lead Sponsor:
Northwestern University
Conditions:
Liver Transplant Rejection
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
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 e...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05325073
Start Date
February 18 2022
End Date
September 30 2024
Last Update
March 15 2024
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611