A Study to Evaluate the Efficacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis (ELIXIR)

Conditions

End-Stage Kidney Disease

Brief summary

Weekly Kt/V urea (V1, V3, V4, V5)

Detailed description

Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5), EPO requirements (V1, V3, V5), Patients’ subjective assessment of fatigue (V1, V3, V5), 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5), 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5), Residual Kidney Function (V1, V3, V4, V5), Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)

Silvio Borrelli, Tommaso Prosdocimi, Mario Bonomini, Francesco Trepiccione, Luca Nardelli et al. (12 authors)

Nephrology Dialysis Transplantation2025-10-01

10.1093/ndt/gfaf116.0689

Interventions

DRUGXylocore Low Strength

DRUGFIXIONEAL “35 Glucosio 1

DRUG36% p/v / 13

DRUG6 mg/ml” in sacca Clear-Flex

DRUGSoluzione per dialisi peritoneale

DRUGbalance 1

DRUG5% Glucose

DRUG1

DRUG25 mmol/l Calcium

DRUGPeritonealdialyselösung

DRUGFIXIONEAL “35 Glucosio 3

DRUG86% p/v/38

DRUG6 mg/ml” in sacca Clear-Flex Soluzione per dialisi peritoneale

DRUGbicaVera 2

DRUG3 % Glucose

DRUG75 mmol/l Calcium

DRUGPHYSIONEAL 35 Glucose 3

DRUG86 % w/v / 38

DRUG6 mg/ml

DRUGPHYSIONEAL 35 Glucose 1

DRUG36 % w/v / 13

DRUGbalance 4

DRUG25% Glucose

DRUGXylocore Medium Strength

DRUGDianeal PDG4 1

DRUG36 %

DRUGbalance 2

DRUG3% Glucose

DRUGbicaVera 4

DRUG25 % Glucose

DRUG25 mmol/l Calcium Peritonealdialyselösung

DRUGPHYSIONEAL 35 Glucose 2

DRUG27 % w/v / 22

DRUG7 mg/ml

DRUGPHYSIONEAL 40 Glucose 1

DRUGDianeal PDG4 2

DRUG27 %

DRUGequiBalance 4

DRUG25% glucosio

DRUG75 mmol/l calcio

DRUGsoluzione per dialisi peritoneale

DRUGDianeal PDG4 3

DRUG86 %

DRUGXylocore High Strength

DRUGFIXIONEAL “35 Glucosio 2

DRUG27% p/v/22

DRUG7 mg/ml” in sacca Clear-Flex

DRUGbicaVera 1

DRUG5 % Glucose

DRUGequiBalance 1

DRUG5% glucosio

DRUGequiBalance 2

DRUG3% glucosio

DRUGPHYSIONEAL 40 Glucose 3

DRUGPHYSIONEAL 40 Glucose 2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Weekly Kt/V urea (V1, V3, V4, V5)	—

Secondary

Measure	Time frame
Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5), EPO requirements (V1, V3, V5), Patients’ subjective assessment of fatigue (V1, V3, V5), 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5), 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5), Residual Kidney Function (V1, V3, V4, V5), Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)	—

Measure

Time frame

Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5), EPO requirements (V1, V3, V5), Patients’ subjective assessment of fatigue (V1, V3, V5), 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5), 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5), Residual Kidney Function (V1, V3, V4, V5), Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)

—

Countries

Denmark, Germany, Italy, Spain, Sweden

Outcome results

None listed