Addition of isradipine (Lomir) results in a better renal function after kidney transplantation: a double-blind, randomized, placebo-controlled, multi-center study.
BACKGROUND
After successful kidney transplantation patients may suffer from the adverse effects due to the use of calcineurin inhibitors. Calcium channel blockers are effective in the treatment of hypertension and may ameliorate cyclosporine- (CsA) induced impairment of renal function after kidney transplantation. Calcium channel blockers may also modulate the immune-system which may result in reduction of acute rejection episodes.


METHODS
From June 1995 till 1997 the effect of isradipine (Lomir) on renal function, incidence and severity of delayed graft function (DGF), and acute rejection after kidney transplantation, was studied in 210 renal 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 (isradipine: 9.1+/-8.7 vs. placebo: 9.3+/-8.1 days). No statistical difference was found 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 thrombosis 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. medication versus 2/165 (1%) on oral medication, P<0.001].


CONCLUSIONS
Addition of isradipine results in a better renal function after kidney transplantation, without effect on incidence or severity of DGF or acute rejection.
Department of Nephrology and Transplantation, University Hospital Rotterdam, The Netherlands.
I C
IC
van Riemsdijk
P G
PG
Mulder
J W
JW
de Fijter
J A
JA
Bruijn
J P
JP
van Hooff
A J
AJ
Hoitsma
A M
AM
Tegzess
W
W
Weimar
D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000494:pharmacology*; D016572:Cyclosporine / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017275:Isradipine / Q000494:pharmacology*; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D013927:Thrombosis / Q000209:etiology
D002121:Calcium Channel Blockers; D016572:Cyclosporine; D017275:Isradipine