A three year randomized, multicenter, prospective, open trial, will be developed
with the aim of studying the influence of antihypertensive therapy on chronic renal failure progression in non-diabetics patients.
The study will compare the effects of an angiotensin converting enzyme inhibitor,
fosinopril, with a slow release calcium antagonist, nifedipine slow release.
Two hundred and fifty patients, with progressively fallug renal function, shom
by an increase of serum creatinine (SCr) of at least 25 % in the 2 years preceding
entry to the study, and SCr levels between 1.5 and 4.0 mg/dl, will be included.
The primary end point of the trial will be the rate of change of SCr (mg/dl/month)
and of the reciprocal of serum creatinine concentration (1/SCr) over time. The secondary end point will be the percentage of patients with a doubling of SCr, progreswith to dialytic therapy, or deah during the study.
Patients with nephrotic syndrome (serum albumin concentration < 3 g %), systemic
disease (including diabetes), severe cardiac or hepatic dysfunction, malignant
or renovascular hypertension, obstructive nephropathy, initial serum potassium
concentration > 5.8 mmol/l and initial serum total cholesterol level ³ 270
mg/dl, will be excluded.
After a «wash out» period of four weeks, patients with arterial blood pressure ³
140/90 will be assigned either to fosinopril (10-30 mg/day) or nifedipine slow release
(30-60 mg/day). In case of insufficient blood pressure control, furosemide (20-
100 mg/d) will be added as a first step and then atenolol (25-100 mg/d) and/or doxazosine
(1-12 mg/d) in order to maintain arterial blood pressure control under
All patients will receive a diet with 4-5 g/day salt content and a protein content
of 0.8-1 g/kg body weight.
At the begining of the study, at 2, 4 and 8 weeks, and every 4 months, the following
parameters will be measured: supine blood pressure after 5 minutes rest,
body weight, SCr, 1/SCr, serum albumin, electrolytes and lipid pattern; urinary protein and urea concentrations and creatinine clearange.
The relation between the progression chronic renal failure and ambulatory blood
presure during 24 hours will be studied in some patients.