drugset / Trial / NCT00708604
Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes
Phase 1
Completed
3 enrolled
City of Hope Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety of islet transplantation in patients with type 1 diabetes who have had a successful kidney transplant and have been maintained for at least three months on anti-rejection medications consisting of any combination of sirolimus, tacrolimus, MMF or prednisone (5 mg/day or less). Another purpose is to determine the effectiveness of an islet transplant in inducing insulin independence and whether or not an islet transplant improves quality of life for kidney transplants patients with type 1 diabetes.
Timeline
- Start
- 2008-10-18
- Primary completion
- 2014-06
- Completion
- 2014-06
Publications
- Background Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
- Background Ryan EA, Paty BW, Senior PA, Bigam D, Alfadhli E, Kneteman NM, Lakey JR, Shapiro AM. Five-year follow-up after clinical islet transplantation. Diabetes. 2005 Jul;54(7):2060-9. doi: 10.2337/diabetes.54.7.2060.
- Background Fiorina P, Folli F, Maffi P, Placidi C, Venturini M, Finzi G, Bertuzzi F, Davalli A, D'Angelo A, Socci C, Gremizzi C, Orsenigo E, La Rosa S, Ponzoni M, Cardillo M, Scalamogna M, Del Maschio A, Capella C, Di Carlo V, Secchi A. Islet transplantation improves vascular diabetic complications in patients with diabetes who underwent kidney transplantation: a comparison between kidney-pancreas and kidney-alone transplantation. Transplantation. 2003 Apr 27;75(8):1296-301. doi: 10.1097/01.TP.0000061788.32639.D9.
- Background Fiorina P, Folli F, Zerbini G, Maffi P, Gremizzi C, Di Carlo V, Socci C, Bertuzzi F, Kashgarian M, Secchi A. Islet transplantation is associated with improvement of renal function among uremic patients with type I diabetes mellitus and kidney transplants. J Am Soc Nephrol. 2003 Aug;14(8):2150-8. doi: 10.1097/01.asn.0000077339.20759.a3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Islet cell transplantation | Cell therapy | — | Other |