Nephrol Dial Transplant (2002) 17: 655-662
© 2002 European Renal Association-European Dialysis and Transplant Association
Preliminary Communication
Combined therapy of tacrolimus and corticosteroids in cyclosporin-resistant or -dependent idiopathic focal glomerulosclerosis: a preliminary uncontrolled study with prospective follow-up
1 Servicio de Nefrologia, 2 Bioquímica, 3 Anatomia Patológica and 4 CIBBIM, Hospital General Valle Hebrón, Barcelona, Spain
Abstract
Background. Cyclosporin has improved the outcome for steroid-resistant patients with focal glomerulosclerosis, but there is a proportion of patients that are either cyclosporin-resistant or suffer relapses, needing long-term therapy to sustain the remission. In these cases, preliminary reports suggest that tacrolimus could be an alternative therapy, but to date the evidence is limited to small series of patients with no long-term follow-up.
Methods. In this study we analysed the efficacy and safety of a combined therapy of tacrolimus and steroids in 25 patients (mean serum creatinine= 1.24±0.49 mg/dl; mean proteinuria=10.2±9.5 g/day; mean serum albumin=2.4±0.58 g/dl) with idiopathic primary focal glomerulosclerosis and proven resistance to or dependence on cyclosporin A.
Results. After a 6 months trial of tacrolimus and steroids, proteinuria decreased in 17 patients (68%) (complete remission in 10 patients (40%), partial remission in two patients (8%) and a moderate reduction in proteinuria to levels <3 g/day was seen in five additional patients (20%)). The only predictor of response to tacrolimus was a previous response to cyclosporin and prednisone, either as a complete or partial remission (remission rate 75% vs 15.3; P=0.036). Mean time to remission was 112±24 days. After tacrolimus discontinuation, 13/17 patients (76%) relapsed and were treated with a second trial of tacrolimus for 1 year, achieving complete remission in five patients (38.4%), partial remission in four patients (30.7%) and reduction of proteinuria <3 g/day in four patients (30.7%). After 2 years of follow-up, 12 patients (48%) were on sustained remission. The main side effect was acute reversible nephrotoxicity (40%). Predictors of renal toxicity were age (P=0.037), baseline creatinine (P=0.046) and tacrolimus trough level (P=0.001).
Conclusions. We conclude that combined therapy of tacrolimus and steroids induce sustained remission of proteinuria in a significant number of patients with idiopathic focal glomerulosclerosis whose disease was not controlled by the standard therapy of steroids and cyclosporin A.
Keywords: corticosteroids; idiopathic focal glomerulosclerosis; nephrotic syndrome; tacrolimus
Notes
This work was presented at the EDTA Congress of Nice September 2000 and has been published in abstract form in Nephrology Dialysis Transplantation.
Correspondence and offprint requests to: A. Segarra, Servicio de Nefrologia, Anexo planta 7a, Hospital Valle Hebrón, Paseo Valle Hebrón 119–129, E-08035 Barcelona, Spain. Email: asem{at}hg.vhebron.es
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