NCT01944852

Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.

Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Pr Eric Goffin · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum : * One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose * One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.

Detailed description

The DiDo study evaluates efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy. The objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (CAPD) patients using incremental peritoneal dialysis (PD) (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used. This is a phase IV open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un Europe. It is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). The duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited. There are 2 periods: a run-in period of 2 months and a treatment period of 18 months.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Icodextrin

Timeline

• Start date: 2013-03-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2013-09-18
• Last updated: 2020-11-10

Locations

1 site across 1 country: Belgium