Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
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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) |
Islet transplantation is an experimental therapy in people with difficult to control Type 1 diabetes. 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.
The subjects participating 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.
Participants will receive a physical and regular blood tests ince a year until April 2014.
Eligibility| Genders Eligible for Study: | Both |
Inclusion Criteria:
- Participation in Clinical Study ITN005CT (NIS01) 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 an MMTT within 12 months of the screening visit.
Exclusion Criteria:
- Inability to understand and sign an informed consent.
- 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
- HbA1C > 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| Contact: NIAID, DAIT Clinical Research and Operations Program | DAITClinicalTrialsGov@niaid.nih.gov |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| Contact: Eduardo Peixoto 305-243-3389 EPeixoto@med.miami.edu | |
| Principal Investigator: Rodolfo Alejandro, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Elaine Javier 617-643-2019 ejavier@partners.org | |
| Principal Investigator: Enrico Cagliero, MD | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Rebecca Schuessler 314-362-4109 rschuess@dom.wustl.edu | |
| Principal Investigator: Daniel C. Brennan, MD | |
| Study Chair: | Daniel C. Brennan, MD | Washington University School of Medicine |
More Information
No publications provided
| 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: | February 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Diabetes Mellitus, Type 1 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 Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013