A clinical research consortium sponsored by NIAID and JDRF
Researchers, doctors and patients

Active Clinical Trials

A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)

Summary coming soon.
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A Phase I Trial of IL-2 and Sirolimus in Recent-onset Type 1 Diabetes Mellitus

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 progression.
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A Phase II study of multiple doses of hOKT3γ-1(Ala-Ala) for new onset type 1 diabetes (AbATE)

hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of type 1 diabetes in patients diagnosed within the past 60 days.
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A Randomized, Double-blind, Single-center, Placebo-controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults with Seasonal Allergic Rhinitis (The GRASS Study)

GRASS is a clinical research study looking at long-term immunity from the symptoms of hay fever. The study is testing the effectiveness of two commercially available tolerance-increasing treatments.
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Abatacept and Cyclophosphamide Combination: Efficacy and Safety Study (ACCESS) for Lupus Nephritis

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.
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An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ARTIST)

Summary coming soon.

ATG and Rituximab in Renal Transplantation (RESTARRT)

Summary coming soon.
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Cytokine production in blood leukocytes of prediabetic children and effect of intranasal insulin

This study is being performed in collaboration with the Finnish Diabetes Prediction and Prevention project that is studying individuals in various stages of prediabetes and who will receive intranasal insulin as part of a secondary prevention trial. The ITN is funding the support of additional laboratory studies that hope to identify biomarkers that can predict the onset of type 1 diabetes, and to learn more about the natural history of the disease.

Effects of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus

Summary coming soon.
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Gradual Withdrawal of Immunosuppression in Patients Receiving a Liver Transplant (AWISH)

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.
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High dose immunosuppression and autologous transplantation for multiple sclerosis (HALT MS)

The HALT-MS study is investigating an experimental treatment of intensive immunosuppression followed by a transplant of the participant’s own stem cells, to see whether it can stabilize multiple sclerosis. Bone marrow CD34+ stem cells are collected from the participant, and transplanted back into the body following treatment with high doses of chemotherapy drugs. This study is for individuals with relapsing-remitting or progressive-relapsing MS, who have experienced relapses while on other MS treatments.
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Immunosuppression Withdrawal for Pediatric Living-Donor Liver Transplant Recipients (WISP-R)

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.
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Inducing Remission in Type 1 Diabetes with Alefacept (T1DAL)

Summary coming soon.
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ITN Registry of Tolerant Kidney Transplant Recipients

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. 


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Pilot Study to Determine the Immunogenicity of Immucothel® and Oral Tolerance Induction with Biosyn Native KLH in Healthy Subjects

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

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.
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Promoting Tolerance to Peanut in High-Risk Children (LEAP)

Infants who suffer from eczema or egg allergy have a 1 in 5 chance of developing peanut allergy by age 5. This study is evaluating whether consuming or avoiding peanut early in life can reduce the risk of peanut allergy in these high risk children.
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Renal Allograft Tolerance through Mixed Chimerism

Summary coming soon.
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Safety and Efficacy of Campath-1H and Tacrolimus Followed By Immunosuppression Withdrawal in Liver Transplantation

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.
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Study of Thymoglobulin to Arrest Type 1 Diabetes (START)

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.
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