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Clinical Trial Details

Trial ID: L0809
Source ID: NCT03994471
Associated Drug: Xylocore Low Strenght, Xylocore Medium Strenght, Xylocore High Strenght
Title: Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.
Acronym: ELIXIR
Status: RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght|DRUG: 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution
Outcome Measures: Primary: 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, 24-week | Secondary: Changes in HbA1c (glycated haemoglobin), Change from baseline value, 6 months|Insulin, Changes from the baseline value, 6 months|LDL cholesterol, Changes from the baseline value, 6 months|HDL cholesterol, Change from the baseline value, 6 months|Serum triglycerides, Change from the baseline value, 6 months|Total cholesterol, Changes from the baseline, 6 months|Hemoglobin, Changes from the baseline value, 6 months|EPO requirements, Change from the baseline, 6 months|Fatigue measured through a validated instrument, Changes from the baseline, 6 months|Peritoneal ultrafiltration, Changes from baseline, 6 months|Diuresis (or 24 hours urinary volume), Changes from baseline, 6 months|Residual renal function, Changes from baseline - measured as the arithmetic mean of urinary urea and creatinine clearance, 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., 6 months
Sponsor/Collaborators: Sponsor: Iperboreal Pharma Srl
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 170
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-12-14
Completion Date: 2024-12
Results First Posted:
Last Update Posted: 2024-06-17
Locations: Aalborg University, Aalborg, Denmark|Aarhus University Hospital, Aarhus, Denmark|Zealand University Hospital, Roskilde, Denmark|Dialysis Center DaVita, Düsseldorf, Germany|Ospedale Madonna del Soccorso, Ascoli Piceno, Italy|Ospedale Santa Maria Annunziata, Bagno A Ripoli, Italy|Azienda Universitaria Ospedaliera di Bari, Bari, Italy|ASST Spedali Civili di Brescia, Brescia, Italy|Ospedale SS. Annunziata, Chieti, Italy|IRCCS Policlinico San Martino, Genova, Italy|Ospedale Civile San Salvatore, L'Aquila, Italy|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|Università della Campania L.Vanvitelli, Napoli, Italy|Azienda Ospedaliera di Padova, Padova, Italy|Ospedale AUSL "Guglielmo da Saliceto", Piacenza, Italy|Ospedale S.Eugenio, Roma, Italy|Ospedale C. e G. Mazzoni, San Benedetto Del Tronto, Italy|Azienda Ospedaliera Terni, Terni, 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 U. Germans Trias i Pujol, Badalona, Spain|Fundaciòn Puigvert, Barcelona, Spain|Hospital Universitario Josep Trueta, Girona, Spain|Fundacion Jimenez Diaz, Madrid, Spain|Hospital Ramón y Cajal, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario Central De Asturias, Oviedo, Spain|Halland County Hospital of Halmstad, Halmstad, Sweden|Karolinska University Hospital, Stockholm, Sweden|Heartlands Hospital, Birmingham, United Kingdom|St Luke's Hospital, Bradford, United Kingdom|University Hospitals Sussex, Brighton, United Kingdom|Kent and Canterbury Hospital, Canterbury, United Kingdom|Hammersmith Hospital, London, United Kingdom|Churchill Hospital, Oxford, United Kingdom|Sheffield Kidney Institute, Sheffield, United Kingdom|University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03994471