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Cytokine

EPO Arm 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EPO effects on Treg induction

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138

31%

Fatigue

23%

Pulmonary

15%

Infection

Cardiac adverse event

Diarrhea

Esophagitis

Hot flashes

Other toxicities

Hemorrhage

Skin

Weight loss

Neuropathy-clinical

Edema

Anemia

Neuropathy-psych

Abdominal cramps

100%

80%

60%

40%

20%

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)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,242 Total Patients Enrolled

Josh Levitsky, MDPrincipal InvestigatorNorthwestern University

4 Previous Clinical Trials

1,053 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the demographic cutoff for this trial above 25 years of age?

"The age range for candidates of this investigation begins at 18 and terminates at 74, as specified in the criteria."

Answered by AI

How many participants is this research endeavor recruiting?

"Affirmative. The information available on clinicaltrials.gov verifies that this trial is actively seeking subjects, having initially been posted on February 18th 2022 and edited most recently on April 5th 2022. A total of 20 individuals are required to be enrolled from 1 medical site."

Answered by AI

What demographic is qualified to register for this research?

"This trial seeks 20 volunteers with a history of non-immune liver transplantation aged 18 to 74. To be considered for admission, participants must satisfy the following prerequisites: male or female gender, age between 18 and 74 years old, over two year period post-transplant experience, prescription of tacrolimus/everolimus immunosuppressant during that time frame, steady dosage regimen in the three months preceding enrolment, capability of providing informed consent both verbally and written down."

Answered by AI

Are participants presently being accepted into this experiment?

"Affirmative. Clinicaltrials.gov corroborates that this research program, which commenced on 18th February 2022, is presently looking for candidates to participate. 20 individuals need to be sourced from 1 medical centre."

Answered by AI