A study to assess the efficacy of lacidipine to prevent the deterioration of renal function in renal transplant patients receiving cyclosporine A as part of their immunosuppressive protocol

Even though immunosuppressant treatment with Cyclosporine A (CsA) has enorm ously improved the success of renal graft cadaveric transplantation, CsA ad ministration is invariably associated to a reduction of glomerular filtrati on rate (GFR) and renal plasma flow (RPF), which in turn causes progressive chronic renal failure. However, CsA-induced haemodynamic changes appear to be prevented by the administration of lacidipine, even at the minimum hype rtensive dose of 2 mg. Therefore, a multicenter, multinational, double-blin d, randomised, parallel-group, placebo controlled study was designed to ass ess the efficacy of lacidipine in preventing renal function deterioration i n newly transplanted patients receiving long term CsA as a part of their im munosuppressive protocol. The primary end point of this study is to compare the effects of lacidipine and placebo (plus standard antihypertensive trea tment if required) on renal function deterioration over a two-year period, with renal function deterioration being evaluated in terms of serum creatin ine values. GFR and RPF long-term changes, the number of episodes of acute rejection and the glomerular morphological changes after the 2-year treatme nt period constitute the secondary efficacy end-points. One-hundred and sixty patients are being recruited in five clinical centres . Immediately before or after renal transplantation, elegible patients are allocated to the initial dose of either lacidipine 2 mg or matching placebo , then titrated up to 4 or 6 mg lacidipine or matching placebo since the se cond week of treatment onwards. Other antihypertensive agents can be added by a stepwise approach in order to maintain diastolic blood pressure below 90 mmHg. Immunosuppressive treatment must be as standardised as possible, a ccording to a triple agents regimen including CsA plus mycophenolate plus p rednisone, Recruitment started at the beginning of 1997. The last patient was expected by March 1998 so that the study will be finished within March 2000. Eighty -nine patients had been allocated to study treatments through 28th November 1997. J Hypertens 16 (suppl 9):S41-43 (C) Lippincott Williams & Wilkins.