BridgeMD
New treatment option for Liver Transplant
Official title EVR and EPO for Liver Transplant Tolerance
ClinicalTrials.gov ID: NCT06832189
What this study is testing
What is Everolimus?
Everolimus is an investigational medicine, being studied as a potential treatment for liver transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, single-arm, multicenter phase 1b study of stable adult liver transplant recipients on a tacrolimus (TAC)-based immunosuppression (IS) regimen who will transition from TAC to Everolimus (EVR), receive five doses of EPO and concurrently initiate phased withdrawal from EVR. The primary objective is to test the safety of administering Everolimus (EVR) and epoetin alfa (EPO) to induce operational tolerance in stable adult liver transplant recipients
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be able to understand and provide informed consent
- 1-10 years post-liver transplant
- Tacrolimus-containing maintenance immunosuppression (IS) regimen without corticosteroid. Mycophenolate mofetil (MMF) dose must be \<=2000 mg daily or...
- Gamma glutamyl transferase (GGT) and alanine transaminase (ALT) \<= upper limit of normal (ULN)
- Estimated glomerular filtration rate (GFR) \>=40 mL/min/1.73 m\^2 using the CKD-EPI 2021 equation
You likely can't join if
- Inability of a subject to comply with study protocol
- Any medical condition requiring chronic systemic corticosteroid, e.g., severe reactive airways disease. Use of inhaled steroids is not an exclusion
- Autoimmune cause of liver disease (including autoimmune hepatitis (AIH), primary sclerosing cholangitis, primary biliary cirrhosis)
- Diagnosis of rejection within 52 weeks prior to screening
- Donor human leukocyte antigen (HLA) typing unavailable or inadequate for assigning donor-specific antibody (DSA)
- Need for uninterrupted anticoagulation
See the full eligibility criteria
Who can join
- Subject must be able to understand and provide informed consent
- 1-10 years post-liver transplant
- Tacrolimus-containing maintenance immunosuppression (IS) regimen without corticosteroid. Mycophenolate mofetil (MMF) dose must be \<=2000 mg daily or mycophenolic acid (MPA) dose\<=1440 mg daily (if on MMF or MPA)...
- Gamma glutamyl transferase (GGT) and alanine transaminase (ALT) \<= upper limit of normal (ULN)
- Estimated glomerular filtration rate (GFR) \>=40 mL/min/1.73 m\^2 using the CKD-EPI 2021 equation
- Female people of reproductive potential must have a negative pregnancy test upon study entry
- Female people with reproductive potential, must agree to use Food and Drug Administration (FDA)-approved methods of birth control for the duration of the study
- people must have current vaccinations or documented immunity as per the Division of Allergy, Immunology, and Transplantation (DAIT) vaccine guidance for people in transplant trials
- Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy. Testing should be conducted using either a purified protein derivative (PPD) or...
- Negative FDA-approved test for human immunodeficiency virus (HIV) diagnosis at screening or as documented in medical record, up to 12 months prior to screening)
- Negative hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening, in people without a history of hepatitis C. If there is a history of treated hepatitis C, then...
- Negative hepatitis B surface antigen and negative hepatitis B core antibody in people without a history of hepatitis B virus (HBV) infection, up to 12 months prior to screening. Those with known hepatitis B infection or...
What rules you out
- Inability of a subject to comply with study protocol
- Any medical condition requiring chronic systemic corticosteroid, e.g., severe reactive airways disease. Use of inhaled steroids is not an exclusion
- Autoimmune cause of liver disease (including autoimmune hepatitis (AIH), primary sclerosing cholangitis, primary biliary cirrhosis)
- Diagnosis of rejection within 52 weeks prior to screening
- Donor human leukocyte antigen (HLA) typing unavailable or inadequate for assigning donor-specific antibody (DSA)
- Need for uninterrupted anticoagulation
- Known active current or history of invasive fungal infection, or mycobacterial infection within 1 year prior to screening
- Human immunodeficiency virus (HIV)-positive
- Serious uncontrolled concomitant major organ disease
- Recipient of non-liver solid organ or bone marrow transplant
- Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks
- Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated in situ cervical cancer. History of hepatocellular carcinoma in the explanted liver is acceptable provided that
- the last alpha fetoprotein obtained within 3 months prior to liver transplantation was \< 400 microg/L, and
- the recipients' explanted liver did not have evidence of increased risk of recurrent cancer, i.e., explant was within the Milan criteria, with no vascular invasion, and with no cholangiocarcinoma morphology
- Neutropenia (absolute neutrophil count or ANC \<1000 microliter) within 4 weeks prior to study enrollment
- History of hypersensitivity to Epoetin (EPO) or mammalian Target of Rapamycin inhibitor (mTOR-I)
- History of angioedema
- History of hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. History of lactose intolerance is not an exclusion
- History of genetic disorders predisposing to thrombosis including but not limited to Factor V Leiden mutation, prothrombin 20210, protein C deficiency, protein S deficiency, antithrombin III deficiency
- History of venous or arterial thrombosis or thromboembolism, acute MI, or thrombotic stroke except for a history of isolated portal vein thrombosis in the setting of hepatic cirrhosis
- History of Budd Chiari syndrome
- Hemoglobin \> 13.5 g/dl
- Plasma fibrinogen or D-dimer level \> ULN
- Planned major surgery within the next 12 months
- Uncontrolled severe hypertension
- Uncontrolled clinically significant cardiac arrhythmia
- Proteinuria with urine protein/creatinine \>0.5 g/g
- Severe hyperlipidemia with total cholesterol \>350 mg/dl or triglycerides \>1000 mg/dl
- Current alcohol, drug, or chemical dependency
- Currently pregnant or nursing
- Current treatment with an estrogen-containing oral contraceptive, or systemic estrogen replacement therapy
- Treatment with an immunomodulatory biological drug within 12 weeks of study entry
- Immunization with live vaccine within 2 weeks of study baseline visit
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Chicago, Illinois, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.