Glomerular filtration rate (GFR) declines during long-term dialysis treatment. In
peritoneal dialysis, blockade of the renin-angiotensin-aldosterone system reduces
GFR decline. Observational studies suggest that similar treatment may preserve kidney
function in hemodialysis (HD).
A multicenter, randomized, placebo-controlled, double-blinded trial, with 1-year follow-up.
Setting & Participants
Adult HD patients with urine output > 300 mL/24 h, HD vintage less than 1 year, and cardiac ejection fraction > 30%. Patients were included from 6 HD centers.
Patients were randomly assigned to placebo or the angiotensin II receptor blocker
irbesartan, 300 mg daily. Target systolic blood pressure (BP) was 140 mm Hg.
Outcomes & Measurements
Primary outcomes were change in GFR measured as the mean of creatinine and urea renal
clearance together with urine volume. Secondary outcomes were change in albuminuria,
renin-angiotensin II-aldosterone hormone plasma levels, and time to anuria.
Of 82 patients randomly assigned (41 patients in each group), 56 completed 1 year
of treatment. The placebo and irbesartan groups were comparable at baseline in terms
of sex balance (26 vs 30 men), mean age (62 vs 61 years), median HD vintage (137 vs
148 days), mean HD time (10 vs 11 h/wk), median urine volume (1.19 vs 1.26 L/d), and mean GFR (4.8 vs 5.7 mL/min/1.73 m2). The target BP level was reached in both groups and BP did not differ significantly
between groups over time. Adverse-event rates were similar. GFR declined by a mean
of 1.7 (95% CI, 1.2-2.3) and 1.8 (95% CI, 1.1-2.4) mL/min/1.73 m2 per year in the placebo and irbesartan groups, respectively. Mean difference (baseline
values minus value at 12 months) between groups was −0.0 (95% CI, −0.8 to 0.8). In
each group, 4 patients became anuric.
GFR decline rates were lower than expected, reducing the power.
At equal BP levels, we found that irbesartan treatment did not affect the decline
in GFR or urine volume significantly during 1 year of treatment in HD patients. Irbesartan
treatment was used safely in the studied population.