Clinical Trials

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.

Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis (STAYCIS)

Principal Investigator:

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.

Category: 

Autoimmune Disease

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Specific Category: 

Multiple Sclerosis

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Status: 

Completed

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE)

Principal Investigator:

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.

Category: 

Autoimmune Disease

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Specific Category: 

Vasculitis

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Status: 

Completed

Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance

Principal Investigator:

George W. Burke | University of Miami | Miami, FL

Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.

Category: 

Transplantation

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Specific Category: 

Kidney Transplantation

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Status: 

Completed

Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

Principal Investigator:

Flavio Vincenti | University of California | San Francisco, CA

Christian Larsen, MD | Emory University | Atlanta, GA

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had kidney transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-HLA identical kidney transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

Category: 

Transplantation

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Specific Category: 

Kidney Transplantation

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Status: 

Completed

Immune System Suppression with Alemtuzumab and Tacrolimus in Liver Transplantation Patients (TILT)

Principal Investigator:

J. Richard Thistlethwaite | University of Chicago | Chicago, IL

This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.

Category: 

Transplantation

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Specific Category: 

Liver Transplantation

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Status: 

Completed

Promoting Tolerance to Common Allergens in High-Risk Children: Global Prevention of Asthma in Children (GPAC) Study

Principal Investigator:

Patrick Holt | University of Western Australia | Perth, AUS

Peter Sly | Telethon Institute for Child Health Research | Perth, AUS

The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.

Category: 

Allergy & Asthma

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Specific Category: 

Asthma⠀

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Status: 

Completed

Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE)

Principal Investigator:

Kevan Herold | Yale University | New Haven, CT

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) can halt the progression of type 1 diabetes in patients diagnosed within the past 60 days.

Category: 

Type 1 Diabetes

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Specific Category: 

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Status: 

Completed

Study of Antithymocyte Globulin for Treatment of New-onset T1DM (START)

Principal Investigator:

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.

Category: 

Type 1 Diabetes

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Specific Category: 

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Status: 

Completed

Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients (WISP-R)

Principal Investigator:

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.

Category: 

Transplantation

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Specific Category: 

Liver Transplantation

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Status: 

Completed

Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH)

Principal Investigator:

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.

Category: 

Transplantation

|

Specific Category: 

Liver Transplantation

|

Status: 

Completed

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