drugset / Trial / NCT01640743
Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study will be to evaluate the effect of different therapeutic immunosuppressive strategies currently employed in common clinical practice on regulatory T lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but it can also lead to mid-term formation of a high amount of regulatory T cells and, consequently, a high grade of tolerance.
Timeline
- Start
- 2010-03
- Primary completion
- 2013-06
- Completion
- 2014-04
Publications
- Background Taber DJ, Weimert NA, Henderson F, Lin A, Bratton CF, Chavin KD, Baliga PK. Long-term efficacy of induction therapy with anti-interleukin-2 receptor antibodies or thymoglobulin compared with no induction therapy in renal transplantation. Transplant Proc. 2008 Dec;40(10):3401-7. doi: 10.1016/j.transproceed.2008.08.130.
- Background Riley JL, June CH, Blazar BR. Human T regulatory cell therapy: take a billion or so and call me in the morning. Immunity. 2009 May;30(5):656-65. doi: 10.1016/j.immuni.2009.04.006.
- Background Anil Kumar MS, Irfan Saeed M, Ranganna K, Malat G, Sustento-Reodica N, Kumar AM, Meyers WC. Comparison of four different immunosuppression protocols without long-term steroid therapy in kidney recipients monitored by surveillance biopsy: five-year outcomes. Transpl Immunol. 2008 Nov;20(1-2):32-42. doi: 10.1016/j.trim.2008.08.005. Epub 2008 Sep 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | — |
| Subject | Methylprednisolone | Other / unclassified | 8 mg | — |
| Subject | Methylprednisolone | Other / unclassified | 16 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | — |
| Subject | Tacrolimus | Small molecule | 0.2 mg/kg | — |
| Subject | thymoglobulins | Unknown | 1 mg/kg | — |
Indications
No indication recorded.