Introduction: Calcineurin inhibitors (CI) introduction was a transcendental event in the transplant medicine history. Actually, CI are considered the cornerstone in the immunosuppression treatment because they have a better short term renal transplant outcomes. However, long term allograft survival can be decreased related to their potential nephrotoxicity. The aim of the present study was to evaluate allograft CI nephrotoxicity prevention with the use of spironolactone.

Methods: A prospective randomized open label controlled trial was conducted in renal transplant patients with immunosuppression based on CI from Nov-2012 to Oct-2015. Patients were randomly allocated to 50mg spironolactone daily from the 8th post-transplant day through follow-up (Treatment group) or not spironolactone (ctrl group). Renal function and histological abnormalities on renal allograft biopsy were evaluated during follow-up.

Results: In this preliminary report 28 patients were analyzed. Ten (35%) and 18 (65%) patients were included on treatment and control group, respectively. No basal differences in demographics, immunological risk, donor type, and CI inhibitor used were found between groups. CI T-12 serum levels through the follow-up were similar in both groups. Basal serum creatinine (SCr) was 1.2[1.0-1.4] mg/dL and 1.1[0.9-1.4] mg/dL (p=NS), and at the end of follow up 1.2[1.0-1.5] mg/dL and 1.2[1-1.6] mg/dL (p=NS) in treatment and control group, respectively. SCr delta change from basal to de end of follow was 0.03[-0.03 a 0.09] mg/dL in treatment group and 0.2[0.08 a 0.36] mg/dL in control group (p=0.04). Acute CI toxicity was present in 9 (90%) patients at 116±63 post-transplant days in the treatment group and 12(67%) patients at 120±88 post-transplant days in the control group (p=NS). Chronic CI toxicity was found in 1 (10%) patient at 287±63 post-transplant days in the treatment group and 8 (44%) patients at 264±137 post-transplant days in the control group (p=0.06). Inflammatory infiltrate percentage was lower for treatment group (2±5% vs 10±15%, p=0.04. Free chronic CI toxicity survive was better in treatment group compared with control group (long Rank 0.04). No adverse events were seen with spironolactone use.

Conclusions: Spironolactone could reduce renal allograft dysfunction and prevents chronic IC toxicity. This results should be confirmed in a study with a bigger sample and longer follow up.

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