Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01309022
First received: March 2, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Diabetes Mellitus, Type 1
Drug: Sirolimus
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Mycophenolic acid

Study Type: Expanded Access     What is Expanded Access?
Official Title: Immunosuppressive Medications for Previous Participants in Clinical Trial ITN005CT (NCT00014911)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

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.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Participation in clinical trial ITN005CT (reference: ClinicalTrials.gov 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309022

Locations
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
Immune Tolerance Network (ITN)
Investigators
Study Chair: Daniel C. Brennan, MD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01309022     History of Changes
Other Study ID Numbers: DAIT ITN040CT
Study First Received: March 2, 2011
Last Updated: August 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Diabetes Mellitus, Type 1
T1D
T1DM
Islets of Langerhans Transplantation
Pancreatic Islets Transplantation
Islet Transplant
Tacrolimus
Sirolimus
Mycophenolate mofetil
Mycophenolic acid

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 11, 2014