Kjærgaard, Krista Dybtved8; Peters, Christian Daugaard8; Jespersen, Bente8; Tietze, Ida N4; Madsen, Jens Kristian8; Pedersen, Birgitte Bang9; Novosel, Marija K6; Laursen, Kathrine Skaaning7; Bibby, Bo Martin10; Strandhave, Charlotte9; Jensen, Jens Dam8
1 Department of Clinical Medicine - Department of Medicine and Nephrology C, Department of Clinical Medicine, Health, Aarhus University2 Department of Clinical Medicine - Nyremedicinsk Afdeling, Medicinsk Center, Aalborg Sygehus Syd, Department of Clinical Medicine, Health, Aarhus University3 Department of Public Health - Department of Biostatistics, Department of Public Health, Health, Aarhus University4 Medicinsk Afdeling, Regionshospitalet Viborg5 Department of Clinical Medicine, Health, Aarhus University6 Department of Medicine, Fredericia Hospital, Fredericia, Denmark.7 Nyremedicinsk Afdeling, Aalborg Sygehus8 Department of Clinical Medicine - Department of Medicine and Nephrology C, Department of Clinical Medicine, Health, Aarhus University9 Department of Clinical Medicine, Health, Aarhus University10 Department of Public Health - Department of Biostatistics, Department of Public Health, Health, Aarhus University
Background: Glomerular filtration rate (GFR) declines during chronic dialysis treatment. In peritoneal dialysis, blockade of the renin-angiotensin-aldosterone system reduces GFR decline. Observational studies suggest that similar treatment may preserve renal function in hemodialysis (HD). Methods: The SAFIR study is a multicenter randomized placebo-controlled double-blinded trial initiated by the investigators with one-year follow-up. Inclusion criteria were adult HD patient with urine output > 300 mL/24h, HD vintage < 1 year, and cardiac ejection fraction > 30%. Patients were included from six HD centers and randomized to placebo or the angiotensin II receptor blocker irbesartan 300 mg daily. Target systolic blood pressure (BP) was 140 mmHg. Outcomes were GFR measured as the mean of creatinine and urea renal clearance, urine volume and time to anuria. Results: Of the 82 patients randomized (placebo n=41/irbesartan n=41), 56 completed one year of treatment. The groups were comparable at baseline (means): males 26/30, age 62/61 years, HD vintage 137/148 days (medians), HD time 10/11 hours/week, urine volume 1.19/1.26 L/24h (medians), GFR 4.8/5.7 mL/min/1.73m2. 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 1.7 (1.2 to 2.3) (mean (95% CI)) mL/min/1.73m2/year in the placebo group and by 1.8 (1.1 to 2.4) mL/min/1.73m2/year in the irbesartan-treated group. Mean difference (baseline-12 months) between groups was -0.0 (-0.8 to 0.8). In each group, four patients became anuric. Conclusions: At equal BP levels, we found that irbesartan treatment did not affect the decline in GFR or urine volume significantly during one-year treatment in HD patients. Irbesartan treatment was safely used in the studied population.
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Annual meeting of the Danish Society of Nephrology, 2014