Double Icodextrin Dose in PD patients the Dido study
Research type
Research Study
Full title
Efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy: the DIDo study
IRAS ID
195854
Contact name
Martin Wilkie
Contact email
Sponsor organisation
Université catholique de Louvain
Eudract number
2011-005274-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 31 days
Research summary
The purpose of this study is to compare the effectiveness and safety of using two bags of Icodextrin daily instead of only one bag in patients who are beginning Continuous Ambulatory Peritoneal Dialysis (CAPD). Icodextrin is a treatment that is used in CAPD and is currently limited to one bag daily. However, some studies seem to show that, for certain patients, the use of two bags daily may be more beneficial and may extend the duration of CAPD treatment. Nevertheless, these studies must be confirmed by more studies that include more patients. This is our intention with the DIDo Study. The study invites patients that have been diagnosed with chronic kidney failure and will begin treatment of this disease with Continuous Ambulatory Peritoneal Dialysis (CAPD. Approximately 160 patients will participate in this study in about 30 centres across Europe. Participants in the study will be randomly allocated to one of the two treatment procedures (a) 1 bag of Icodextrin and 2 bags of glucose daily, or (b) 2 bags of Icodextrin and 1 bag of glucose daily. Over a period of 18 months participants will have 7 visits of approximately 2h linked to the study conduct. In each visit the physician will perform a physical examination, collection of both routine and study blood samples, collection of a urine sample and dialysate sample (participant will be asked to collect these samples in the 24hrs before your visit), a peritoneal equilibrium test, an echocardiogram, an electrocardiogram, asked to complete a quality of life questionnaire.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0536
Date of REC Opinion
22 Jul 2016
REC opinion
Favourable Opinion