Efficacy and Safety of XyloCore Peritoneal Dialysis Solution. (ELIXIR)
End Stage Renal Disease
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring peritoneal dialysis, ESRD
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Diagnosed with ESRD and treated with CAPD in the last 3 months
- In a 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 2 to 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)
Sites / Locations
- Aarhus University Hospital
- Herlev og Gentofte Hospital
- Kolding Medicinske Sygedomme
- Zealand University Hospital
- Dialysis Center DaVita
- Ospedale Madonna del SoccorsoRecruiting
- Azienda Universitaria Ospedaliera di Bari
- Ospedale SS. AnnunziataRecruiting
- Ospedale Leopoldo Parodi Delfino
- A.O.U. Ospedali Riuniti di FoggiaRecruiting
- ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
- Azienda Ospedaliera Universitaria di Modena
- AOU Università degli studi della Campania
- Università della Campania L.Vanvitelli
- Ospedale AUSL "Guglielmo da Saliceto"
- Ospedale S.Eugenio
- Policlinico Gemelli
- Policlinico Umberto I
- Ospedale C. e G. MazzoniRecruiting
- Azienda Ospedaliera Terni
- Azienda Ospedaliera Universitaria Integrata di Verona
- Ospedale San Bortolo
- University Hospital A Coruña Fundación Profesor Novoa Santos
- Hospital U. Germans Trias i Pujol
- Fundaciòn Puigvert
- Hospital Universitario Josep Trueta
- Fundacion Jimenez Diaz
- Hospital Doce de Octubre
- Hospital Ramón y Cajal
- Hospital Universitario La Paz
- Hospital Universitario Central De AsturiasRecruiting
- Halland County Hospital of HalmstadRecruiting
- Karolinska University Hospital
- Heartlands Hospital
- St Luke's HospitalRecruiting
- Kent and Canterbury Hospital
- Hammersmith HospitalRecruiting
- Churchill Hospital
- Royal Berkshire Hospital
- Sheffield Kidney Institute
- University Hospitals of North Midlands
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
XyloCore peritoneal dialysis solution
Glucose peritoneal dialysis solution
Patients will receive 2 to 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.
Patients randomized to glucose solution will continue the 2 to 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.