Efficacy and safety of a Double Icodextrin Dose in ederly patients, starting treatment by Continuous Ambulatory Peritoneal Dialysis (CAPD)

Phase 1

• Conditions: Patients with chronic renal failure who are starting a Continuous Ambulatory Peritoneal Dialysis (CAPD) as first line dialyse.; MedDRA version: 16.0Level: LLTClassification code 10007184Term: CAPDSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-005274-30-BE
• Lead Sponsor: niversité catholique de Louvain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-19
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Run-in period
-Incident CAPD patients who require incremental PD and in whom at least 1.5L dialysate can be safely instilled,
- Creatinine clearance <20ml/min
-Age = 65 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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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 the signature of the informed consent form,
-History of drug or alcohol abuse within 3 months prior to the signature of the informed consent form.
Treatment period
-Severe symptomatic arterial hypotension at the end of 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, psycho-social reasons).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified