Efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy: the DIDo study - DIDo

niversité catholique de Louvain0 个研究点目标入组 160 人开始时间: 2012年4月19日最近更新: 2020年6月2日

试验速览

暂无简介。

•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

•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).

发起方

niversité catholique de Louvain