Is NCT06832189 recruiting in San Francisco, CA?

Yes, NCT06832189 is currently recruiting participants at its San Francisco, CA location. This liver transplant clinical trial is actively enrolling qualified participants.

How do I join the liver transplant clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Liver Transplant Clinical Trial in San Francisco, CA

About This Liver Transplant Study in San Francisco

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

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). Tacrolimus level must be \<8 ng/ml on the 2 most recent laboratory results within 3 months.

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 subjects of reproductive potential must have a negative pregnancy test upon study entry

Female subjects with reproductive potential, must agree to use Food and Drug Administration (FDA)-approved methods of birth control for the duration of the study

Subjects must have current vaccinations or documented immunity as per the Division of Allergy, Immunology, and Transplantation (DAIT) vaccine guidance for subjects 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 interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB. Subjects with a positive test for LTBI must complete appropriate therapy for LTBI. LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC)

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 subjects without a history of hepatitis C. If there is a history of treated hepatitis C, then documentation of two consecutive negative hepatitis C virus (HCV) quantitative RNA polymerase chain reaction (PCR) tests separated by at least 3 months is required. Untreated subjects with positive HCV antibody and a single negative quantitative HCV RNA are eligible. Historical negative HCV RNA results are acceptable in the above two cases with positive HCV antibody

Negative hepatitis B surface antigen and negative hepatitis B core antibody in subjects without a history of hepatitis B virus (HBV) infection, up to 12 months prior to screening. Those with known hepatitis B infection or positive hepatitis B surface antigen or positive hepatitis B core antibody must be on antiviral therapy and have negative HBV DNA quantitative PCR at screening

Exclusion Criteria

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 study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT06832189) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Liver Transplant Treatment Options in San Francisco, CA

If you're searching for liver transplant treatment options in San Francisco, CA, this clinical trial (NCT06832189) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced liver transplant specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all liver transplant clinical trials near you to find additional studies recruiting in your area.

Liver Transplant Clinical Trial in San Francisco, CA

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