Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD), over a 6-month study period.
Patients should be enrolled if they are receiving 1, 2 or 3 diurnal exchanges of one of the following PD solutions (standard treatment): Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose) - and - one bag of Extraneal (7.5% Icodextrin) for the long-dwell exchange. Patients will be centrally randomized to the investigational product (XyloCore) or the glucose-only PD solution active comparator. Patients randomized to the control group will continue with their prescription of standard treatment with 1, 2 to 3 daily (short-dwell) exchanges of Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance PD solution. Patients randomized to XyloCore will receive XyloCore Low, Medium or High Strength according to the osmotic strength (glucose concentration) of their prerandomization prescribed PD solution. All patients will keep being prescribed Extraneal (7.5% Icodextrin) for the nocturnal (long-dwell) exchange. The osmotic strength and number of diurnal short dwell exchanges may be modified by the investigator as clinically required. PD prescriptions in both treatment arms should be tailored to reach the minimum target of a total Kt/V of \> 1.7 per week throughout the study. A stratified randomization scheme will be employed to ensure balanced allocation across the two treatment groups of patients with diabetes and of patients treated with only 1 diurnal exchange. Randomization will be performed centrally via a web-based system according to a computer-generated randomization list. The study is open-label with blinded evaluator (primary endpoint), without blinding of patients or clinical staff.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine
Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.
Total weekly Kt/Vurea
To measure solutes and calculate peritoneal and renal Kt/V (summing up to total Kt/V), dialysate outflow and urine covering 24 hours will be collected, the volumes will be determined, and a blood sample will be taken
Time frame: 24-week
Changes in HbA1c (glycated haemoglobin)
Change from baseline value
Time frame: 6 months
Insulin
Changes from the baseline value
Time frame: 6 months
LDL cholesterol
Changes from the baseline value
Time frame: 6 months
HDL cholesterol
Change from the baseline value
Time frame: 6 months
Serum triglycerides
Change from the baseline value
Time frame: 6 months
Total cholesterol
Changes from the baseline
Time frame: 6 months
Hemoglobin
Changes from the baseline value
Time frame: 6 months
EPO requirements
Change from the baseline
Time frame: 6 months
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Aalborg University
Aalborg, Denmark
NOT_YET_RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGZealand University Hospital
Roskilde, Denmark
RECRUITINGDialysis Center DaVita
Düsseldorf, Germany
RECRUITINGOspedale Madonna del Soccorso
Ascoli Piceno, Italy
RECRUITINGOspedale Santa Maria Annunziata
Bagno a Ripoli, Italy
NOT_YET_RECRUITINGAzienda Universitaria Ospedaliera di Bari
Bari, Italy
RECRUITINGASST Spedali Civili di Brescia
Brescia, Italy
NOT_YET_RECRUITINGOspedale SS. Annunziata
Chieti, Italy
RECRUITINGIRCCS Policlinico San Martino
Genova, Italy
NOT_YET_RECRUITING...and 31 more locations
Fatigue measured through a validated instrument
Changes from the baseline
Time frame: 6 months
Peritoneal ultrafiltration
Changes from baseline
Time frame: 6 months
Diuresis (or 24 hours urinary volume)
Changes from baseline
Time frame: 6 months
Residual renal function
Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
Time frame: 6 months
Adverse Events
Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.
Time frame: 6 months