Krista Dybtved Kjaergaard1, Christian Daugaard Peters2, Bente Jespersen2, Ida Nørager Tietze3, Jens Kristian Madsen4, Birgitte Bang Pedersen5, Marija Kristina Novosel6, Kathrine Skaaning Laursen5, Bo Martin Bibby7, Charlotte Strandhave5, Jens Dam Jensen2. 1. Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: krista@ki.au.dk. 2. Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark. 3. Department of Internal Medicine, Regional Hospital Viborg, Viborg, Denmark. 4. Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark. 5. Department of Nephrology, Aalborg University Hospital, Aalborg, Denmark. 6. Department of Medicine, Fredericia Hospital, Fredericia, Denmark. 7. Department of Public Health, Institute of Biostatistics, Aarhus University, Aarhus, Denmark.
Abstract
BACKGROUND: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). STUDY DESIGN: A multicenter, randomized, placebo-controlled, double-blinded trial, with 1-year follow-up. SETTING & PARTICIPANTS: Adult HD patients with urine output >300mL/24h, HD vintage less than 1 year, and cardiac ejection fraction >30%. Patients were included from 6 HD centers. INTERVENTION: Patients were randomly assigned to placebo or the angiotensin II receptor blocker irbesartan, 300mg daily. Target systolic blood pressure (BP) was 140mm 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. RESULTS: 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 11h/wk), median urine volume (1.19 vs 1.26L/d), and mean GFR (4.8 vs 5.7mL/min/1.73m(2)). 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/1.73m(2) 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. LIMITATIONS: GFR decline rates were lower than expected, reducing the power. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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). STUDY DESIGN: A multicenter, randomized, placebo-controlled, double-blinded trial, with 1-year follow-up. SETTING & PARTICIPANTS: Adult HDpatients with urine output >300mL/24h, HD vintage less than 1 year, and cardiac ejection fraction >30%. Patients were included from 6 HD centers. INTERVENTION: Patients were randomly assigned to placebo or the angiotensin II receptor blocker irbesartan, 300mg daily. Target systolic blood pressure (BP) was 140mm 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. RESULTS: 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 11h/wk), median urine volume (1.19 vs 1.26L/d), and mean GFR (4.8 vs 5.7mL/min/1.73m(2)). 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/1.73m(2) 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. LIMITATIONS: GFR decline rates were lower than expected, reducing the power. CONCLUSIONS: 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 HDpatients. Irbesartan treatment was used safely in the studied population.
Authors: Yoshitsugu Obi; Connie M Rhee; Anna T Mathew; Gaurang Shah; Elani Streja; Steven M Brunelli; Csaba P Kovesdy; Rajnish Mehrotra; Kamyar Kalantar-Zadeh Journal: J Am Soc Nephrol Date: 2016-05-11 Impact factor: 10.121
Authors: Christian Daugaard Peters; Krista Dybtved Kjaergaard; Jens Dam Jensen; Kent Lodberg Christensen; Charlotte Strandhave; Ida Noerager Tietze; Marija Kristina Novosel; Bo Martin Bibby; Bente Jespersen Journal: PLoS One Date: 2015-06-01 Impact factor: 3.240
Authors: Jenny I Shen; Anjali B Saxena; Maria E Montez-Rath; Tara I Chang; Wolfgang C Winkelmayer Journal: Nephrol Dial Transplant Date: 2017-05-01 Impact factor: 5.992