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Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309022
Expanded Access Status : No longer available
First Posted : March 4, 2011
Last Update Posted : February 9, 2016
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Drug: Sirolimus Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Mycophenolic acid

Detailed Description:

Study acronym: EXIIST - Extended Immunosuppression in Islet Transplantation

Islet transplantation is an experimental therapy in people with difficult to control Type 1 diabetes (T1D). Insulin producing cells (islets) are isolated from a pancreas. After the cells are prepared, the islets are put into the subject's liver. These transplanted islets may produce insulin that the subject's islets can no longer make. In order to help keep up the function of the transplanted islets, immunosuppressive medications must be given indefinitely or for as long as the study doctor determines is necessary. The medications serve to modify the immune system that normally tries to destroy (reject) new islets.

Participants in this study have received up to three islet cell infusions as a previous participant in the ITN005CT (NIS01) protocol. They also received 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.

Routine study follow-up visits will occur on an annual and -as warranted basis.

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Study Type : Expanded Access
Official Title: Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Sirolimus
    Obtained by prescription and given at doses used in record NCT00014911.
    Other Name: Rapamune®
  • Drug: Tacrolimus
    Obtained by prescription and given at doses used in record NCT00014911.
    Other Name: Prograf®
  • Drug: Mycophenolate mofetil
    Obtained by prescription and given at doses used in record NCT00014911.
    Other Names:
    • MMF
    • CellCept
  • Drug: Mycophenolic acid
    Obtained by prescription and given at doses used in record NCT00014911.
    Other Name: Myfortic®

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Participation in clinical trial ITN005CT (reference: record NCT00014911) at Harvard University (Massachusetts General Hospital), Washington University, or University of Miami.
  • Immunosuppressive regimen consisting of a single agent or some combination from among the following: tacrolimus, sirolimus, mycophenolate mofetil, and mycophenolic acid.
  • Willingness of participants to use an approved method of contraception before, during, and 12 weeks after study participation.
  • Peak C-peptide >0.1 pmol/mL during a mixed meal tolerance test (MMTT) within 12 months of the screening visit.

Exclusion Criteria:

  • Inability to understand and sign the informed consent document for this study.
  • Any medical condition which in the opinion of the investigator should preclude participation.
  • Serum creatinine > 1.6 mg/dL
  • Insulin requirement > 1.0 IU/kg/day
  • Hemoglobin A1C (HbA1C) result > 12%
  • Hypoglycemia unawareness defined as the absence of adequate autonomic symptoms at plasma glucose levels of < 54 mg/dL requiring treatment with glucagon, outside assistance, or treatment in an emergency room or hospital within a 12-month period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309022

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
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Study Chair: Daniel C. Brennan, MD Washington University School of Medicine
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT01309022    
Other Study ID Numbers: DAIT ITN040CT
EXIIST ( Other Identifier: Immune Tolerance Network )
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Diabetes Mellitus, Type 1
Islets of Langerhans Transplantation
Pancreatic Islets Transplantation
Islet Transplant
Mycophenolate mofetil
Mycophenolic acid
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents