Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
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| ClinicalTrials.gov Identifier: NCT01309022 |
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Expanded Access Status :
No longer available
First Posted : March 4, 2011
Last Update Posted : February 9, 2016
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| 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:
- MMF
- CellCept
- Drug: Mycophenolic acid
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.Other Name: Myfortic®
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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: 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
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 | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| Study Chair: | Daniel C. Brennan, MD | Washington University School of Medicine |
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov 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 |
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Diabetes Mellitus, Type 1 T1D T1DM Islets of Langerhans Transplantation Pancreatic Islets Transplantation |
Islet Transplant Tacrolimus Sirolimus Mycophenolate mofetil Mycophenolic acid |
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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 Sirolimus Tacrolimus 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 |