The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.
Non randomized, pilot, prospective, open-label trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg). Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter. Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL).
Nephrology Department. Hospital Vall d'Hebró
Barcelona, Barcelona, Spain
Nephrology Department. Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelone, Spain
Percentage of biopsy-confirmed acute rejection episodes
To describe cumulative biopsy-confirmed acute rejection in both groups by intention to treat analysis.
Time frame: 6 months
Percentage of steroid-sensitive acute rejection episodes
To describe the percentage of steroid-sensitive acute rejections rejection in both groups by intention to treat analysis.
Time frame: 6 months
Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies.
To describe the need for antibody treatment in acute rejection episodes in both groups by intention to treat analysis.
Time frame: 6 months
Renal function estimated by Modification of Diet in Renal Disease (MDRD) formula.
To describe renal function measured by MDRD in both groups by intention to treat and "on therapy" analysis.
Time frame: 12 months
Proteinuria measured in g/day
To describe proteinuria in g/day in both groups by intention to treat analysis.
Time frame: 6 months
Histology at month 6 protocol kidney allograft biopsy
To describe histology at month 6 in both groups by intention to treat and "on therapy" analysis.
Time frame: 6 months
Percentage of patients with negative ELISPOT
To describe percentage of patients with negative ELISPOT in both groups by intention to treat and "on therapy" analysis.
Time frame: 6 months
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Percentage of patients in group A requiring CNI introduction.
To describe the percentage of patients in group A requiring CNI introduction.
Time frame: 24 months
Percentage of patients presenting adverse events requiring study withdrawal
To describe adverse events in the whole group ("screening failure" plus "intention to treat") in both treatments groups.
Time frame: 24 months
Percentage of biopsy-confirmed acute rejection episodes
To describe cumulative biopsy-confirmed acute rejection in both groups by intention to treat analysis.
Time frame: 12 months
Percentage of steroid-sensitive acute rejections rejection episodes
To describe the percentage of steroid-sensitive acute rejections rejection in both groups by intention to treat analysis.
Time frame: 12 months
Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies
To describe the need for antibody treatment in acute rejection episodes in both groups by intention to treat analysis.
Time frame: 12 months
Proteinuria measured in g/day
To describe proteinuria in g/day in both groups by intention to treat analysis.
Time frame: 12 months
Percentage of patients with negative ELISPOT
To describe percentage of patients with negative ELISPOT in both groups by intention to treat and "on therapy" analysis.
Time frame: 12 months