Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Phase 4

Active, not recruiting

• Conditions: Liver Transplant Rejection
• Interventions: Drug: Erythropoietin

• Registration Number: NCT05325073
• Lead Sponsor: Northwestern University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-18
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Primary Completion: 2023-05-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPO Arm	Erythropoietin	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States