CClinicalTrials.gg
Active, not recruitingNCT05325073Updated Mar 15, 2024

Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

A Phase 4 interventional study of Erythropoietin in Liver Transplant Rejection, sponsored by Northwestern University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Northwestern University · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Transplant Rejection
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Other
    EPO Arm

    Drug: Erythropoietin

Interventions

  • DrugErythropoietin

    Erythropoietin

06

What researchers measure

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05325073
Lead sponsor
Northwestern University
Responsible party
Josh Levitsky (Professor, Northwestern University) — Principal investigator
First posted
Apr 13, 2022
Start date
Feb 18, 2022
Primary completion
May 23, 2023
Completion
Sep 30, 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Josh Levitsky, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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