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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004183-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XyloCore peritoneal dialysis solution | Experimental | 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. |
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| Glucose peritoneal dialysis solution | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c (glycated haemoglobin) | Change from baseline value | 6 months |
| Insulin | Changes from the baseline value | 6 months |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arduino Arduini, MD | Contact | +39.333.6409595 | a.arduini@iperboreal.com |
| Name | Affiliation | Role |
|---|---|---|
| Arduino Arduini, MD | Iperboreal Pharma | Study Director |
| Werner Kleophas, MD | DaVita Deutschland AG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Not yet recruiting | Aalborg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39205396 | Derived | Bonomini M, Davies S, Kleophas W, Lambie M, Reboldi G, Liberato LD, Divino-Filho JC, Heimburger O, Ortiz A, Povlsen J, Iacobelli M, Prosdocimi T, Arduini A. Rationale and design of ELIXIR, a randomized, controlled trial to evaluate efficacy and safety of XyloCore, a glucose-sparing solution for peritoneal dialysis. Perit Dial Int. 2025 Jan;45(1):17-25. doi: 10.1177/08968608241274106. Epub 2024 Aug 28. |
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Randomization will be performed centrally via a web-based system, with stratification according to the presence or absence of diabetes.
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The study cannot be blinded. The assessment of the primary end-point will be performed by a blinded, third party, independent assessor.
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| 1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution | Drug | 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. |
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| 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 |
| Aarhus University Hospital | Recruiting | Aarhus | Denmark |
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| Zealand University Hospital | Recruiting | Roskilde | Denmark |
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| Dialysis Center DaVita | Recruiting | Düsseldorf | Germany |
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| Ospedale Madonna del Soccorso | Recruiting | Ascoli Piceno | Italy |
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| Ospedale Santa Maria Annunziata | Not yet recruiting | Bagno a Ripoli | Italy |
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| Azienda Universitaria Ospedaliera di Bari | Recruiting | Bari | Italy |
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| ASST Spedali Civili di Brescia | Not yet recruiting | Brescia | Italy |
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| Ospedale SS. Annunziata | Recruiting | Chieti | Italy |
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| IRCCS Policlinico San Martino | Not yet recruiting | Genova | Italy |
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| Ospedale Civile San Salvatore | Recruiting | L’Aquila | Italy |
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| ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco | Recruiting | Milan | Italy |
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| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Not yet recruiting | Milan | Italy |
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| Azienda Ospedaliera Universitaria di Modena | Recruiting | Modena | Italy |
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| AOU Università degli studi della Campania | Recruiting | Naples | Italy |
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| Università della Campania L.Vanvitelli | Recruiting | Naples | Italy |
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| Azienda Ospedaliera di Padova | Not yet recruiting | Padova | Italy |
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| Ospedale AUSL "Guglielmo da Saliceto" | Recruiting | Piacenza | Italy |
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| Ospedale S.Eugenio | Not yet recruiting | Roma | Italy |
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| Ospedale C. e G. Mazzoni | Recruiting | San Benedetto del Tronto | Italy |
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| Azienda Ospedaliera Terni | Recruiting | Terni | Italy |
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| Ospedale San Giovanni Bosco | Recruiting | Torino | Italy |
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| Azienda Ospedaliera Universitaria Integrata di Verona | Recruiting | Verona | Italy |
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| University Hospital A Coruña Fundación Profesor Novoa Santos | Recruiting | A Coruña | Spain |
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| Hospital U. Germans Trias i Pujol | Recruiting | Badalona | Spain |
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| Fundaciòn Puigvert | Recruiting | Barcelona | Spain |
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| Hospital Universitario Josep Trueta | Recruiting | Girona | Spain |
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| Fundacion Jimenez Diaz | Recruiting | Madrid | Spain |
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| Hospital Ramón y Cajal | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
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| Hospital Universitario Central De Asturias | Recruiting | Oviedo | Spain |
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| Halland County Hospital of Halmstad | Recruiting | Halmstad | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| Heartlands Hospital | Recruiting | Birmingham | United Kingdom |
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| St Luke's Hospital | Recruiting | Bradford | United Kingdom |
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| University Hospitals Sussex | Recruiting | Brighton | United Kingdom |
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| Kent and Canterbury Hospital | Recruiting | Canterbury | United Kingdom |
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| Hammersmith Hospital | Recruiting | London | United Kingdom |
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| Churchill Hospital | Recruiting | Oxford | United Kingdom |
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| Sheffield Kidney Institute | Recruiting | Sheffield | United Kingdom |
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| University Hospitals of North Midlands | Recruiting | Stoke-on-Trent | United Kingdom |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C488051 | Physioneal 40 |
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