Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
- Conditions
- End Stage Renal Disease
- Interventions
- Drug: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High StrenghtDrug: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
- Registration Number
- NCT03994471
- Lead Sponsor
- Iperboreal Pharma Srl
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XyloCore peritoneal dialysis solution XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght Patients will receive 1, 2 or 3 daily (short-dwell) exchanges with XyloCore of an osmotic strength comparable to their pre-randomization prescription of glucose peritoneal dialysis solution (XyloCore Low, Medium and High Strenght have an osmotic strength comparable to Physioneal, Fixioneal or Dianeal 1.36%, 2.27%, 3.86% glucose, respectively, and Balance, Bicavera, Bicanova or Equibalance with 1.5%, 2.5%, 4.25% glucose, respectively). All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange. Glucose peritoneal dialysis solution 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution Patients randomized to glucose solution will continue the 1, 2 or 3 daily (short-dwell) exchanges of Physioneal 40 or 35, Fixioneal 40 or 35 or Dianeal (1.36%, 2.27%, 3.86% glucose), Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.5%, 4.25% glucose) with the same osmotic strength of their pre-randomization prescription. All patients will receive Extraneal (7.5% Icodextrin) for nocturnal (long-dwell) exchange.
- Primary Outcome Measures
Name Time Method Total weekly Kt/Vurea 24-week 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
- Secondary Outcome Measures
Name Time Method Changes in HbA1c (glycated haemoglobin) 6 months Change from baseline value
Insulin 6 months Changes from the baseline value
LDL cholesterol 6 months Changes from the baseline value
HDL cholesterol 6 months Change from the baseline value
Serum triglycerides 6 months Change from the baseline value
Total cholesterol 6 months Changes from the baseline
Hemoglobin 6 months Changes from the baseline value
EPO requirements 6 months Change from the baseline
Fatigue measured through a validated instrument 6 months Changes from the baseline
Peritoneal ultrafiltration 6 months Changes from baseline
Diuresis (or 24 hours urinary volume) 6 months Changes from baseline
Residual renal function 6 months Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance
Adverse Events 6 months 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.
Related Research Topics
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Trial Locations
- Locations (41)
Ospedale SS. Annunziata
🇮🇹Chieti, Italy
IRCCS Policlinico San Martino
🇮🇹Genova, Italy
Ospedale Civile San Salvatore
🇮🇹L'Aquila, Italy
Azienda Ospedaliera Terni
🇮🇹Terni, Italy
Ospedale Madonna del Soccorso
🇮🇹Ascoli Piceno, Italy
Ospedale Santa Maria Annunziata
🇮🇹Bagno A Ripoli, Italy
University Hospitals of North Midlands
🇬🇧Stoke-on-Trent, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Ospedale AUSL "Guglielmo da Saliceto"
🇮🇹Piacenza, Italy
Fundaciòn Puigvert
🇪🇸Barcelona, Spain
St Luke's Hospital
🇬🇧Bradford, United Kingdom
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Sheffield Kidney Institute
🇬🇧Sheffield, United Kingdom
Hospital Universitario Central De Asturias
🇪🇸Oviedo, Spain
Aalborg University
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Zealand University Hospital
🇩🇰Roskilde, Denmark
Azienda Universitaria Ospedaliera di Bari
🇮🇹Bari, Italy
ASST Spedali Civili di Brescia
🇮🇹Brescia, Italy
Dialysis Center DaVita
🇩🇪Düsseldorf, Germany
ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
🇮🇹Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria di Modena
🇮🇹Modena, Italy
AOU Università degli studi della Campania
🇮🇹Napoli, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Università della Campania L.Vanvitelli
🇮🇹Napoli, Italy
Ospedale S.Eugenio
🇮🇹Roma, Italy
Ospedale C. e G. Mazzoni
🇮🇹San Benedetto Del Tronto, Italy
Ospedale San Giovanni Bosco
🇮🇹Torino, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
University Hospital A Coruña Fundación Profesor Novoa Santos
🇪🇸A Coruña, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital U. Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Halland County Hospital of Halmstad
🇸🇪Halmstad, Sweden
University Hospitals Sussex
🇬🇧Brighton, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Hospital Universitario Josep Trueta
🇪🇸Girona, Spain