A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-YEAR TRIAL TO STUDY THE EFFECT OF NITRENDIPINE ON CHRONIC RENAL-TRANSPLANT FUNCTION

The ongoing multicenter, randomized, double-blind, placebo-controlled trial investigates the effect of nitrendipine on kidney function after renal transplantation. Renal transplant recipients (6th-12th postoper ative week, serum creatinine <3 mg/dl) were divided into a normotensiv e (diastolic blood pressure <90 mmHg) and a hypertensive group (diasto lic blood pressure greater than or equal to 90, <115 mmHg). Normotensi ve patients are randomly treated for 104 weeks with nitrendipine 2 X 5 mg daily or placebo, hypertensive patients with 2 x 10 mg - 2 x 20 mg nitrendipine daily or placebo and in case of inefficacy with addition al antihypertensive drugs. Primary end point of the study is the renal transplant function. The trial was started in June 1990. One hundred and eight patients were included into the normotensive and 138 patient s into the hypertensive group. Renal allograft function? cyclosporine trough levels and the donor characteristics were not different between the normotensive and hypertensive groups at entry into the study. Aft er 12 months there was no significant change of renal transplant funct ion in both groups. Cyclosporine trough levels were also similar in th e normotensive and hypertensive group after 12 months. As expected, bl ood pressure decreased significantly after 12 months from 150 +/- 17/9 5 a 11 mmHg to 141 +/- 16/90 +/- 9 mmHg in the hypertensive group (p < 0.01). In contrast, in the normotensive group blood pressure increased significantly from 128 +/- 12/80 +/- 6 mmHg to 135 +/- 15/86 +/- 8 mm Hg (p <0.001). No normotensive but 4 hypertensive patients developed g raft failure during the first 12 months of the study.