Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

NCT ID: NCT05325073

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2024-09-30

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.

Conditions

Liver Transplant Rejection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

EPO Arm

Group Type: OTHER

Erythropoietin

Intervention Type: DRUG

Erythropoietin

Interventions

Erythropoietin

Erythropoietin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Josh Levitsky

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh Levitsky, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00215838

Identifier Type: -

Identifier Source: org_study_id