A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF NIFEDIPINE ONEARLY RENAL-ALLOGRAFT FUNCTION

A double-blind, randomized, placebo-controlled study was conducted to determine the effect of nifedipine on early renal allograft function w hen added to a triple therapy immunosuppression regime comprising low- dose cyclosporin (CsA), prednisolone and azathioprine. Fifty adult cad averic renal allograft recipients were randomized to placebo (group P n = 17), nifedipine 10mg preoperatively and 20mg b.d. postoperatively for 48 h, followed by matching placebo for 3 months (group NS n = 16) or nifedipine 10 mg preoperatively and 20 mg b.d. postoperatively for 3 months (group NL n = 17). Donor and recipient exclusion criteria inc luded recent calcium antagonist treatment. At 3 months after transplan tation mean GFR adjusted for graft loss was significantly higher in gr oup NL than in NS (mean +/- SD 61 +/- 28 versus 34 +/- 25 ml/min/1.73 m2; P < 0.05), group P being intermediate (45 +/- 34 ml/min/1.73 m2). Similarly, effective renal blood flow (ERBF) at 3 months was higher in group NL than in groups P and NS (mean +/- SD 351 +/- 175 versus 216 +/- 166 and 220 +/- 162 ml/min/1.73 m2; P < 0.05). The differences wer e not significant by 6 months post-transplantation. This study suggest s that oral nifedipine commenced preoperatively and continued for 3 mo nths following transplantation has beneficial effects on early renal a llograft function when incorporated as part of an immunotherapy regime n based on cyclosporin.