Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Liver Transplant Rejection Clinical Trial

Official title:

Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05325073
• Other study ID #: STU00215838
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: September 30, 2024
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Rejection

Intervention

Drug:
• Erythropoietin
Erythropoietin

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPO effects on Treg induction	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	12 weeks