Liver Transplant RejectionPhase 4NCT05325073
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
A Phase 4 study testing Erythropoietin in people with Liver Transplant Rejection, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this proof-of-concept study is to EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. The main question[s] it aims to answer [is/are]: EPO increases the frequency, stability and/or function of Treg in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Liver Transplant Rejection
- What is being tested?
- Erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this proof-of-concept study is to EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. The main question[s] it aims to answer [is/are]:
- EPO increases the frequency, stability and/or function of Treg in liver transplant recipients.
- EPO will have a greater effect on Treg induction in everolimus vs. tacrolimus-treated LTR.
Participants who are stable liver transplant recipients on immunosuppression monotherapy with Tacrolimus or Everolimus will
- A single dose of erythropoietin 10,000 IU
- Blood samples for Treg and other immune assessments before (W0) and after EPO W4 and W12).
Read the detailed description
This is a single-center, proof-of-concept study that will evaluate EPO in stable, liver transplant participants on immunosuppression monotherapy with Tacrolimus or Everoliumus to \[primary objective]. Approximately 20 participants will be enrolled who are males or females aged 18 to 74 years with a history of liver transplantation performed more than two years ago for non-immune causes. They must be receiving a stable immunosuppressive monotherapy regimen (tacrolimus or everolimus) for at least three months before enrollment.
Participants will receive a single dose of erythropoietin 10,000 IU. The study duration is 12 weeks.
The primary outcome is to define EPO effects on Treg induction in liver transplant recpients in vivo. We will use flow cytometry to analyze the phenotype of peripheral blood monocluear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lympohocyte subset frequencies, including Tregs. Secondary outcome is to delineate the regulatory functional capabilities of EPO induced Tregs in liver transplant recipients, in vivo. We will determineTREG function at baseline and after treatment in both arms by suppression assays. Finally, we will confirm the safety of EPO in liver transplant recipients by monitoring CBC and liver parameters, as well as any clinical symptoms, at weeks 4 and 12 visits.
- Conditions
- Liver Transplant Rejection
- Being tested
- Erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called EPO
Erythropoietin
| Study group | Role | What they receive |
|---|---|---|
| EPO Arm | Other | This is a single center study in which stable liver transplant recipients on immunosuppression monotherapy with Tacrolimus or Everolimus were given a single dose of 10,000 IU erythropoietin (EPO). Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in White Blood Cell Count
Change in the number of white blood cells in the blood. Measured in thousand cells per microliter. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Medication Trough
Change in the medication concentration measured just before the next scheduled dose. Measured in ng/mL. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Hemoglobin
Change in the amount of hemoglobin in red blood cells. Measured in g/dL. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Creatine
Change in the amount of creatine. Measured in mg/dL. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Glomerular Filtration Rate (GFR)
Change in the Glomerular Filtration Rate (GFR). Measured in mL/min/1.73 m². Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Secondary outcomes (5)
Change in Alanine Aminotransferase (ALT)
Change in the Alanine Aminotransferase (ALT) concentration. Measured in units/L. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Aspartate Aminotransferase (AST)
Change in the Aspartate Aminotransferase (AST) concentration. Measured in units/L. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Total Bilirubin
Change in the amount of bilirubin. Measured in mg/dL. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Alkaline Phosphatase
Change in the concentration of Alkaline Phosphatase. Measured in units/L. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Change in Platelets
Change in the number of platelets. Measured in thousand platelets per microliter. Calculated as value at 12 weeks minus the value at baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start18 Feb 2022
- Primary completion23 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josh Levitsky, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325073
- Sponsor's protocol ID
- STU00215838
- Status last verified
- Sep 2025
- First submitted
- 5 Apr 2022
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT05325073
- Acronym / sponsor ID
- STU00215838
- Conditions
- Liver Transplant Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proof-of-concept study is to EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. The main question[s] it aims to answer [is/are]:
- EPO increases the frequency, stability and/or function of Treg in liver transplant recipients.
- EPO will have a greater effect on Treg induction in everolimus vs. tacrolimus-treated LTR.
Participants who are stable liver transplant recipients on immunosuppression monotherapy with Tacrolimus or Everolimus will
- A single dose of erythropoietin 10,000 IU
- Blood samples for Treg and other immune assessments before (W0) and after EPO W4 and W12).
Detailed description
This is a single-center, proof-of-concept study that will evaluate EPO in stable, liver transplant participants on immunosuppression monotherapy with Tacrolimus or Everoliumus to \[primary objective]. Approximately 20 participants will be enrolled who are males or females aged 18 to 74 years with a history of liver transplantation performed more than two years ago for non-immune causes. They must be receiving a stable immunosuppressive monotherapy regimen (tacrolimus or everolimus) for at least three months before enrollment.
Participants will receive a single dose of erythropoietin 10,000 IU. The study duration is 12 weeks.
The primary outcome is to define EPO effects on Treg induction in liver transplant recpients in vivo. We will use flow cytometry to analyze the phenotype of peripheral blood monocluear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lympohocyte subset frequencies, including Tregs. Secondary outcome is to delineate the regulatory functional capabilities of EPO induced Tregs in liver transplant recipients, in vivo. We will determineTREG function at baseline and after treatment in both arms by suppression assays. Finally, we will confirm the safety of EPO in liver transplant recipients by monitoring CBC and liver parameters, as well as any clinical symptoms, at weeks 4 and 12 visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPO Arm | Other | Drug: ErythropoietinThis is a single center study in which stable liver transplant recipients on immunosuppression monotherapy with Tacrolimus or Everolimus were given a single dose of 10,000 IU erythropoietin (EPO). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropoietinAlso: EPOErythropoietin | Drug | EPO Arm |
Primary outcome
Change in White Blood Cell Count
Time frame: 12 weeks
Change in the number of white blood cells in the blood. Measured in thousand cells per microliter. Calculated as value at 12 weeks minus the value at baseline.
Change in Medication Trough
Time frame: 12 weeks
Change in the medication concentration measured just before the next scheduled dose. Measured in ng/mL. Calculated as value at 12 weeks minus the value at baseline.
Change in Hemoglobin
Time frame: 12 weeks
Change in the amount of hemoglobin in red blood cells. Measured in g/dL. Calculated as value at 12 weeks minus the value at baseline.
Change in Creatine
Time frame: 12 weeks
Change in the amount of creatine. Measured in mg/dL. Calculated as value at 12 weeks minus the value at baseline.
Change in Glomerular Filtration Rate (GFR)
Time frame: 12 weeks
Change in the Glomerular Filtration Rate (GFR). Measured in mL/min/1.73 m². Calculated as value at 12 weeks minus the value at baseline.
5 secondary outcomes
Change in Alanine Aminotransferase (ALT)
Time frame: 12 weeks
Change in Aspartate Aminotransferase (AST)
Time frame: 12 weeks
Change in Total Bilirubin
Time frame: 12 weeks
Change in Alkaline Phosphatase
Time frame: 12 weeks
Change in Platelets
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Levitsky, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythropoietin in people with Liver Transplant Rejection, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in White Blood Cell Count (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.