IDEAL
Trial question
What is the role of early initiation of dialysis in patients with stage V CKD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 828
828 patients (286 female, 542 male).
Inclusion criteria: patients ≥ 18 years of age with progressive CKD and an eGFR between 10.0 and 15.0 mL/min/1.73 m² of body-surface area.
Key exclusion criteria: younger than 18 years of age, estimated GFR < 10.0 mL/min, plans to receive a kidney transplant from a live donor within the next 12 months, recently diagnosed cancer that was likely to affect survival, or unable to provide written informed consent.
Interventions
N=404 early dialysis initiation (initiation of dialysis when the estimated GFR was 10.0-14.0 mL/min).
N=424 late dialysis initiation (initiation of dialysis when the estimated GFR was 5.0-7.0 mL/min).
Primary outcome
All-cause death
37.6%
36.6%
37.6 %
28.2 %
18.8 %
9.4 %
0.0 %
Early dialysis
initiation
Late dialysis
initiation
No significant
difference ↔
No significant difference in all-cause death (37.6% vs. 36.6%; HR 1.04, 95% CI 0.83 to 1.3).
Secondary outcomes
No significant difference in the incidence of CV events (10.9/100 py vs. 8.8/100 py; HR 1.23, 95% CI 0.97 to 1.56).
Borderline significant increase in the incidence of infectious events (12.4/100 py vs. 14.3/100 py).
Safety outcomes
No significant difference in frequency of adverse events.
Conclusion
In patients ≥ 18 years of age with progressive CKD and an eGFR between 10.0 and 15.0 mL/min/1.73 m² of body-surface area, early dialysis initiation was not superior to late dialysis initiation with respect to a all-cause death.
Reference
Cooper BA, Branley P, Bulfone L et al. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19.
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