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
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1||Drug: Sirolimus Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Mycophenolic acid|
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|
|Official Title:||Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)|
- 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:
- Drug: Mycophenolic acid
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.Other Name: Myfortic®
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 ClinicalTrials.gov identifier (NCT number): NCT01309022
|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|
|St. Louis, Missouri, United States, 63110|
|Study Chair:||Daniel C. Brennan, MD||Washington University School of Medicine|