Steroid or tacrolimus withdrawal in renal transplant recipients using sirolimus.
de Sandes Freitas TV, Harada KM et al.International urology and nephrology. 43(4): 1221-1228, 2011.
Aims
To compare the short-term transplant outcomes and adverse event profile of tacrolimus withdrawal versus prednisone withdrawal from a sirolimus-containing immunosuppressive regimen in kidney transplant recipients.
Interventions
Steroid withdrawal versus tacrolimus withdrawal 3 months after transplantation. All patients received sirolimus, tacrolimus and steroid without induction therapy. All patients were given sulfamethoxazole with trimethoprim for Pneumocystis jiroveci prophylaxis.
Participants
47 living donor de novo renal transplant recipients.
Outcomes
The primary efficacy endpoint was the incidence of first biopsy confirmed acute rejection episode at 12 months. Secondary efficacy endpoints included renal function evaluated by estimation of serum creatinine and calculated creatinine clearance, and patient and graft survival. Safety assessments included adverse events, opportunistic infections, malignancies, causes of graft loss and death and. new onset diabetes.
Follow-up
12 months
CET Conclusions
No difference in efficacy and safety end points was demonstrated, but the trial is not sufficiently powered to identify any significant differences.
Data analysis
Per protocol analysis
Trial registration
Not reported