Short-term results of calcineurin-free and steroid-free immunosuppression protocol in live-donor renal allotransplantation: a prospective, randomized, controlled study

ObjectivesThe aim of this study was to investigate the efficacy and safety of steroid-free and calcineurin-free immunosuppressive regimen using sirolimus (SRL) and mycophenolate mofetil (MMF) after 3 months of kidney transplantation in low-risk, living, renal allotransplant recipients.Patients and methodsWe carried out a randomized, prospective, and controlled study including 50 low immunological risk patients who received their living renal allograft in the period between July 2012 and June 2014 at Mansoura urology and nephrology center’s dialysis and renal transplantation unit. All the recruited patients were regularly followed-up for 12 months after transplantation at our center.ResultsPatients were randomized 3 months after transplantation either to continue on tacrolimus and MMF or to be shifted to SRL with MMF. At 6 months after transplantation, the value of the mean estimated glomerular filtration rate was significant higher in the SRL group versus the tacrolimus group (144.7±28.5 vs. 128.4±44.9, respectively, P=0.039). However, at the end of the year, this significant difference disappeared between both groups. Twenty-four hours protein and hypercholesterolemia were significantly higher in the SRL group. On the other hand, hypertension at 1 year after transplantation was significantly lower in the SRL group. We experienced only one grade 1A acute cellular rejection in the SRL group and only borderline changes in each group with stable graft functions.ConclusionSteroid-free, calcineurin-free immunosuppressive protocol is a suitable choice for low immunological risk renal transplant recipients but with a close and strict follow-up plan to avoid and treat any unwanted events. Adopting steroid-free, calcineurin-free regimens should be accompanied with protocol biopsy assessment to discover any histopathological abnormalities even before they are clinically detectable.