The Double-Icodextrin Dose Randomized Controlled Trial of a Double Icodextrin Dose for Older Patients on Incremental Continuous Ambulatory Peritoneal Dialysis

Abstract

Introduction

Icodextrin enhances ultrafiltration (UF) in patients on peritoneal dialysis (PD) but is restricted to 1 bag/d, according to regulatory authorities. The Double-Icodextrin Dose (DIDo) study is a prospective randomized trial investigating the superiority and safety of using 2 bags/d versus 1 bag/d of icodextrin to extend incremental (3 bags/d) continuous ambulatory PD (CAPD) duration in older incident patients.

Methods

After a 2-month “run-in” period, the patients were randomized to 2 icodextrin (“double dose”) + 1 glucose or 1 icodextrin (“single dose”) + 2 glucose dialysates daily. The primary end point was a composite of excessive use of hypertonic dialysates, transfer to another dialysis modality (automated PD [APD], nonincremental CAPD, or hemodialysis) or death at month 9. Secondary end points included mortality, daily UF, technique survival, rates of peritonitis and hospitalizations, and safety at month 18.

Results

Forty-one patients were randomized to double dose and 42 to single-dose icodextrin. Baseline characteristics were well-balanced between groups. At month 9, the proportion of patients who discontinued 3 exchanges/d was similar between those receiving the double and the single icodextrin dose (16 [39%] vs. 21 [50%]; HR: 0.69; 95% confidence interval: 0.35–1.33). The results were similar at month 18. Patients in the double dose icodextrin had higher net UF and less hypertonic dialysates use. Rates of peritonitis, hospitalizations, residual urine output decline and serious adverse events (SAEs) were similar between both groups.

Conclusion

In older patients on incremental CAPD, the double icodextrin dose did not reduce the primary outcome incidence compared with the single icodextrin dose. Significantly enhanced UF was observed in the double icodextrin dose group and no safety issue was identified.