Addition of isradipine (Lomir) results in a better renal function after kidney transplantation: A double-blind, randomized, placebo-controlled, multicenter study

Background. After successful kidney transplantation patients may suffer fro m the adverse effects due to the use of calcineurin inhibitors. Calcium cha nnel blockers are effective in the treatment of hypertension and may amelio rate cyclosporine- (CsA) induced impairment of renal function after kidney transplantation. Calcium channel blockers may also modulate the immune-syst em which may result in reduction of acute rejection episodes. Patients and methods. From June 1995 till 1997 the effect of isradipine (Lo mir) on renal function, incidence and severity of delayed graft function (D GF), and acute rejection after kidney transplantation, was studied in 210 r enal transplant recipients, who were randomized to receive isradipine (n=98 ) or placebo (n=112) after renal transplantation in a double-blind fashion. Results. In the isradipine group renal function was significantly better at 3 and 12 months (P=0.002 and P=0.021) compared with the placebo group. DGF was present, in both groups: isradipine: (28+6)/98 (35%); placebo: (35+9)/ 112 (40%), P=0.57. Severity of DGF was comparable in both groups (isradipin e: 9.1+/-8.7 vs. placebo: 9.3+/-8.1 days). No statistical difference was fo und in incidence or severity of biopsy-proven acute rejection [isradipine: (42+6)/98 (49%) versus placebo: (46+9)/112 (49%), P=1.00]. Renal vein throm bosis was observed in eight patients, This proved to be associated with the route of administration of the study medication [6/45 (13%) on i.v. medica tion versus 2/165 (1%) on oral medication, P<0.001]. Conclusions. Addition of isradipine results in a better renal function afte r kidney transplantation, without effect on incidence or severity of DGF or acute rejection.