Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Recruiting · NCT03994471 · Interventional (participants receive a specific treatment) · Lead sponsor: Iperboreal Pharma Srl
View the official record on ClinicalTrials.gov →Interventions studied
1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD SolutionXyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥18 years
- Diagnosed with ESRD and treated with CAPD in the last 3 months
- In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events
- Have not experienced peritonitis episodes in the last 3 months
- In treatment with prescribed Extraneal (nocturnal exchange bag solution) for at least 1 month
- In treatment with 1, 2 or 3 diurnal exchange bag solution of prescribed Phisioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.25%, 2.3%, 4.5% glucose)
- Kt/V urea measurement \> 1.7 per week at Baseline Visit
- Followed/treated by the participating clinical Center/Investigator in the last three months
- Understanding the nature of the study and providing their informed consent to participation.
Exclusion criteria
- History of drug or alcohol abuse in the six months prior to entering the protocol
- In treatment with androgens
- Clinically significant abnormal liver function test (ɣ-GT \> 4 times the upper normal limit)
- Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- Expected patient's survival shorter than the trial duration
- History of L-Carnitine therapy or use in the month prior to entering the protocol
- Have used any investigational drug in the 3 months prior to entering the protocol
- Female patients who are pregnant or breast-feeding.
- Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
- Patients affected by Primary Hyperoxaluria as per known medical therapy
- Patients with serum levels of uric acid \> 7.2 mg/dl (male and postmenopausal women) or \> 6.0 mg/dl (premenopausal women)
- Patients with a major cardiovascular event in the last 3 months
- Patients with advanced cardiac failure (NYHA 4)
- Hypersensitivity to any of the constituents of the study IMPs.
- Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC.
- Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator.
- History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator.
Where it is running
41 locations listed.
- University Hospital A Coruña Fundación Profesor Novoa Santos - A Coruña, Spain
- Aalborg University - Aalborg, Denmark
- Aarhus University Hospital - Aarhus, Denmark
- Ospedale Madonna del Soccorso - Ascoli Piceno, Italy
- Hospital U. Germans Trias i Pujol - Badalona, Spain
- Ospedale Santa Maria Annunziata - Bagno a Ripoli, Italy
- Fundaciòn Puigvert - Barcelona, Spain
- Azienda Universitaria Ospedaliera di Bari - Bari, Italy
- Heartlands Hospital - Birmingham, United Kingdom
- St Luke's Hospital - Bradford, United Kingdom
- ASST Spedali Civili di Brescia - Brescia, Italy
- University Hospitals Sussex - Brighton, United Kingdom
- Kent and Canterbury Hospital - Canterbury, United Kingdom
- Ospedale SS. Annunziata - Chieti, Italy
- Dialysis Center DaVita - Düsseldorf, Germany
- IRCCS Policlinico San Martino - Genova, Italy
- Hospital Universitario Josep Trueta - Girona, Spain
- Halland County Hospital of Halmstad - Halmstad, Sweden
- Hammersmith Hospital - London, United Kingdom
- Ospedale Civile San Salvatore - L’Aquila, Italy
- Fundacion Jimenez Diaz - Madrid, Spain
- Hospital Ramón y Cajal - Madrid, Spain
- Hospital Universitario La Paz - Madrid, Spain
- ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco - Milan, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Italy
- Azienda Ospedaliera Universitaria di Modena - Modena, Italy
- AOU Università degli studi della Campania - Naples, Italy
- Università della Campania L.Vanvitelli - Naples, Italy
- Hospital Universitario Central De Asturias - Oviedo, Spain
- Churchill Hospital - Oxford, United Kingdom
- Azienda Ospedaliera di Padova - Padova, Italy
- Ospedale AUSL "Guglielmo da Saliceto" - Piacenza, Italy
- Ospedale S.Eugenio - Roma, Italy
- Zealand University Hospital - Roskilde, Denmark
- Ospedale C. e G. Mazzoni - San Benedetto del Tronto, Italy
- Sheffield Kidney Institute - Sheffield, United Kingdom
- Karolinska University Hospital - Stockholm, Sweden
- University Hospitals of North Midlands - Stoke-on-Trent, United Kingdom
- Azienda Ospedaliera Terni - Terni, Italy
- Ospedale San Giovanni Bosco - Torino, Italy
- Azienda Ospedaliera Universitaria Integrata di Verona - Verona, Italy