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

• Status: Completed
• Trial end date: 2020-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pr Eric Goffin
• Treatments: Icodextrin

Criteria

Inclusion Criteria:

Run-in period

• Incident CAPD patients who require incremental PD and in whom a 1.5L dialysate can be safely instilled,

• Creatinine clearance < 20 ml / min (calculated with the modification of the Diet in renal Disease [MDRD] formula),

• Age ≥ 60 years,

• Patients willing and able to give written informed consent and comply with the requirements of the study protocol.

Treatment period

• Patients having successfully completed the run-in period (achieving euvolemia)

Exclusion Criteria:

Run-in period

• Contraindication for CAPD according to local practice,

• Life expectancy < 6 months,

• Known allergy to icodextrin (cloudy dialysate or skin rash),

• Need for amino-acid prescription,

• Treatment with any investigational product within 30 days prior to signature of the informed consent form (ICF)

• History of drug or alcohol abuse within 3 months prior to the signature of the ICF.

Treatment period

• Severe symptomatic arterial hypotension at the end the run-in period in the Investigator's opinion,

• Excessive ultrafiltration (UF) during the run-in period,

• Allergy to icodextrin discovered during the run-in period,

• Impossibility to achieve adequate PD regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psychosocial reasons)