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Cytokine

Erythropoietin for Liver Transplant Rejection

Phase 4
Waitlist Available
Led By Josh Levitsky, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing if a drug called EPO can help increase the success of liver transplants by making the recipient's immune system more tolerant.

Who is the study for?
This trial is for adults aged 18-74 who had a liver transplant over 2 years ago due to non-immune causes and are on stable immunosuppressive monotherapy. They must be able to consent and not have high hemoglobin levels, severe hypertension, end-stage renal disease, history of blood clots or heart issues, active cancer, allergies to erythropoietin or certain other substances.
What is being tested?
The study tests if Erythropoietin (EPO) can increase the number and effectiveness of Tregs in liver transplant recipients. It will compare the effects of EPO in patients treated with either tacrolimus or everolimus to find a better treatment strategy towards tolerance.
What are the potential side effects?
Potential side effects include reactions at the injection site, increased risk of blood clots, high blood pressure episodes, potential stroke risks, and possible allergic reactions among those sensitive to erythropoietin or related products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EPO effects on Treg induction

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138
31%
Fatigue
23%
Pulmonary
15%
Infection
8%
Cardiac adverse event
8%
Diarrhea
8%
Esophagitis
8%
Hot flashes
8%
Other toxicities
8%
Hemorrhage
8%
Skin
8%
Weight loss
8%
Neuropathy-clinical
8%
Edema
8%
Anemia
8%
Neuropathy-psych
8%
Abdominal cramps
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
Supportive Care (Step 1)
Erythropoietin (Step 1)
Erythropoietin (Cross-over; Step 2)
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EPO ArmExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erythropoietin
FDA approved

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,647 Previous Clinical Trials
958,643 Total Patients Enrolled
Josh Levitsky, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
1,053 Total Patients Enrolled
~2 spots leftby Nov 2025
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