Efficacy and safety of a Double Icodextrin Dose in ederly patients, starting treatment by Continuous Ambulatory Peritoneal Dialysis (CAPD)
- Conditions
- Patients with chronic renal failure who are starting a Continuous Ambulatory Peritoneal Dialysis (CAPD) as first line dialyse.MedDRA version: 15.0Level: LLTClassification code 10007184Term: CAPDSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2011-005274-30-FR
- Lead Sponsor
- niversité catholique de Louvain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Run-in period
-Incident CAPD patients who require incremental PD and in whom a 2L 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
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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident CAPD patients using incremental PD (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.;Secondary Objective: The secondary objective is to demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues.<br>;Primary end point(s): The primary endpoint will be the proportion of patients stopping 3 bags / day for the following reasons:<br>-Use of > 15 % hypertonic glucose dialysate 3.86 % or > 30 % hypertonic glucose dialysate 2.27 % over a 4-week period,<br>-Transfer of the patient to another dialysis method (haemodialysis [HD], automated peritoneal dialysis [APD], CAPD with > 3 bags / day) for any reason,<br>-Death of the patient.<br>;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at 9 months (visit 5)
- Secondary Outcome Measures
Name Time Method