drugset / Trial / NCT01309022
Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
Expanded access
No longer available
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
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.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Publications
- Background Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems JA, Bretzel RG, Bertuzzi F, Froud T, Kandaswamy R, Sutherland DE, Eisenbarth G, Segal M, Preiksaitis J, Korbutt GS, Barton FB, Viviano L, Seyfert-Margolis V, Bluestone J, Lakey JR. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318-30. doi: 10.1056/NEJMoa061267.
- Results Brennan DC, Kopetskie HA, Sayre PH, Alejandro R, Cagliero E, Shapiro AM, Goldstein JS, DesMarais MR, Booher S, Bianchine PJ. Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. Am J Transplant. 2016 Feb;16(2):509-17. doi: 10.1111/ajt.13458. Epub 2015 Oct 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Sirolimus | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | Oral |
| Background | mycophenolic acid | Small molecule | — | Oral |