At a glance
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Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation: a Randomized Study
In Brief
A clinical study evaluating Tacrolimus + Methylprednisolone and Tacrolimus + Everolimus + Methylprednisolone for Kidney Transplantation. Completed, enrolled 58 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Induction therapy: Methylprednisolone (500 mg), thymoglobulins (1.5 mg/Kg/die, beginning 1 hour before transplantation) and 1 mg/Kg/die during the following 3 days. Maintenance therapy: Tacrolimus dosage will be 0.2 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels
Induction therapy: Methylprednisolone (500 mg), thymoglobulins (2.5 mg/Kg/die, beginning 1 hour before transplant) and Mycophenolate mofetil (1000 mg) and no immunosuppressive therapy for the following 3 days (WOFIE hypothesis), and for day 4-5-6 thymoglobulins (1.0 mg/Kg/die). Maintenance therapy: Tacrolimus dosage will be 0.1 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels