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Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

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ClinicalTrials.gov Identifier: NCT01309022
Expanded Access Status : No longer available
First Posted : March 4, 2011
Last Update Posted : February 9, 2016
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date March 2, 2011
First Posted Date March 4, 2011
Last Update Posted Date February 9, 2016
 
Descriptive Information
Brief Title Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
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.
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.

Study Type Expanded Access
Intervention
  • 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®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01309022
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators Immune Tolerance Network (ITN)
Investigators
Study Chair: Daniel C. Brennan, MD Washington University School of Medicine
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date February 2016