Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

NCT05325073 — Phase 4, Active not recruiting, 9 participants, Northwestern University

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Registry	NCT05325073
Status	Active not recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	9 (Actual)
Sponsor	Northwestern University (Other)
Conditions	Liver Transplant Rejection
Interventions	Erythropoietin (Drug)
Dates	start 2022-02-18, primary completion 2023-05-23, completion 2024-09-30 (estimated), first posted 2022-04-13, last updated 2024-03-15
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
EPO Arm	Other	Drug: Erythropoietin

Erythropoietin (Drug): Erythropoietin

+Outcome measures

Primary outcomes

EPO effects on Treg induction [12 weeks]: We will use flow cytometry to analyze the phenotype of peripheral blood mononuclear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lymphocyte subset frequencies, including Tregs

+Eligibility

Sex: All, ages: 18 Years to 74 Years

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

+Locations (1)

Facility	City	Country	Status
Northwestern University	Chicago, Illinois	United States

+Investigators

Josh Levitsky, MD, Principal investigator, Northwestern University