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Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05325073
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
15.8
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
Actual Study Start Date :
Feb 18, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: EPO Arm

Drug: Erythropoietin
Erythropoietin

Outcome Measures

Primary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Josh Levitsky, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Josh Levitsky, Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT05325073
Other Study ID Numbers:
  • STU00215838
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Epoetin Alfa

Study Results

No Results Posted as of Apr 13, 2022