Building on clinical trial and laboratory research insights from the past decade, the ITN has focused and deliberate strategies to achieving tolerance in each disease area. The research supported by the ITN has unlocked new therapeutic approaches and discovered new biomarkers that promise to change the way physicians treat patients. Explore ITN clinical trials below by using a search term or by sorting the specific trial categories. If you have questions or want more information about ITN clinical trials, contact us.
Stephen Gitelman, University of California, San Francisco, CA
Thymoglobulin is an antibody preparation that is commonly used to treat and prevent organ transplant rejection. The START trial aims to determine whether Thymoglobulin treatment can halt the progression of newly diagnosed type 1 diabetes when given within 3 months of diagnosis. This study is for people aged 12-35 years old.
Sandy Feng, University of California San Francisco, San Francisco, CA
Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.
Abraham Shaked, University of Pennsylvania, Philidelphia, PA
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes and cancer. This study is investigating whether liver transplant recipients can slowly be taken off these drugs under medical supervision.
Daniel C. Brennan, MD, Washington University, St. Louis, MO
This study is for participants who have received up to three islet cell infusions as a previous participant in the ITN005CT study. Study participants will receive a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil (MMF, Cellcept®), and/or mycophenolic acid (MPA, Myfortic®).) This protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make C-peptide.
Gideon Lack, MD, Evelina Children's Hospital, London, UK
This is a follow-on study to the ITN’s LEAP trial to evaluate the persistence of tolerance to peanut, and whether continued consumption of peanuts throughout life is required in order to be able to safely eat peanuts without reacting.
Lloyd Mayer, MD, Mount Sinai Medical Center, New York, NY
The purpose of this study is to determine whether Immucothel, a Keyhole Lymphocyte Antigen (KLH) product, can trigger an immune response when ingested orally and create "oral tolerance" to KLH. If not, Immucothel will be tested with another agent to enhance the immune response.
Kenneth Newell, Emory University, Atlanta, GA
Laurence Turka, Harvard Medical School, Boston, MA
Anil Chandraker, Harvard Medical School, Boston, MA
This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression.
Gordon Weir, Joslin Diabetes Center, Boston, MA
Terry Strom, Beth Israel Deconess, Boston, MA
The RETAIN study is evaluating a protein called alpha-1 antitrypsin (AAT) in recently diagnosed type 1 diabetes patients.
Andreas Tzakis, MD, Jackson Memorial Hospital, Miami, FL
Panagiotis Tryphonopoulos, MD, University of Miami, Miami, FL
This study aims to identify which study participants - all of whom previously received a liver transplant under Campath-1H immunosuppression - exhibit specific tolerogenic genotypes. Our hypothesis is that patients who exhibit these genotypes might be good candidates for future immunosuppression withdrawal.
David H. Sachs, MD, Harvard Medical School
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.
David Wofsy, University of California, San Francisco, CA
Betty Diamond, Feinstein Institute, Manhasset, NY
This study is for people with systemic lupus who have developed complications in their kidneys, called 'lupus nephritis.' The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.
Jack Antel, Montreal Neurological Institute, Montreal, Quebec, Canada
This study aims to evaluate the safety and tolerability of a 5 mg dose of the study drug, NBI-5788, for treatment of relapsing-remitting multiple sclerosis patients. A prior phase 2 trial conducted with this drug demonstrated suggestive evidence of treatment benefit with a 5 mg dose of NBI-5788.
Jorma Ilonen, University of Turku, Turku, Finland
This clinical trial is being performed in collaboration with the Finnish Diabetes Prediction and Prevention project and is studying individuals in various stages of prediabetes who receive intranasal insulin as part of a secondary prevention trial. The ITN is funding the support of additional laboratory studies to identify biomarkers that can predict the onset of type 1 diabetes and to learn more about the natural history of the disease.
Kenneth Newell, Emory University, Atlanta, GA
Immunosuppressive drugs are all that separate transplant recipients from rejecting their transplanted organs. The ITN Registry of Tolerant Kidney Transplant Recipients is searching for those rare kidney transplant recipients who have stopped their immunosuppression, but for some reason have not rejected their transplants. If you have received a kidney transplant and have been off all immunosuppressive medications for 1 year and have good kidney function, or if you received your kidney from an identical twin, you may be eligible to participate.
Florian Kern, Institut für Medizinische Immunologie, Berlin, Germany
This study seeks to optimize and standardize an existing assay which allows the T-cell response directed against in transplant recipients who undergo immune tolerance induction. This study employs a rapid laboratory test that would enable the transplant physicians to look at the patient's immune response to this model virus.
Jean Paul Soullilou, Institute de Transplantation, Nantes, France
This trial investigates the landscape of blood T lymphocytes in patients with active forms of multiple sclerosis. The goal of the study is to demonstrate T cell receptor (TCR) patterns that are specific for disease activity at the patient level and then to use this “TCR signature” to follow regulation of auto reactive T cells, particularly during tolerance induction.
Carla Greenbaum, Benaroya Research Institute, Seattle, WA
This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes.
Marcus Clark, University of Chicago, Chicago, IL
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.
John H. Stone, Johns Hopkins University, Baltimore, MD
Ulrich Specks, Mayo Clinic, Rochester, MN
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating adults with WG and MPA.
Scott Zamvil, University of California, San Francisco, CA
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients.