Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

NCT05325073 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STU00215838
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EPO Arm

OTHER

Drug: Erythropoietin

Interventions

Erythropoietin DRUG

Erythropoietin

EPO Arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Josh Levitsky, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: February 18, 2022
• Primary Completion: May 23, 2023
• Study Completion: September 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)