drugset
drugset / Trial / NCT03994471

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

NCT03994471 ↗

Phase 3 Recruiting 170 enrolled Iperboreal Pharma Srl
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2022-12-14
Primary completion
2026-12-31
Completion
2027-04-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bicanova Unknown 1.25 % Other
Comparator Bicanova Unknown 2.3 % Other
Comparator Bicanova Unknown 4.5 % Other
Comparator Dianeal Unknown 1.36 % Other
Comparator Dianeal Unknown 2.27 % Other
Comparator Dianeal Unknown 3.86 % Other
Comparator Equibalance Unknown 1.25 % Other
Comparator Equibalance Unknown 2.3 % Other
Comparator Equibalance Unknown 4.5 % Other
Comparator Fixioneal Unknown 1.36 % Other
Comparator Fixioneal Unknown 2.27 % Other
Comparator Fixioneal Unknown 3.86 % Other
Comparator ISOXAFLUTOLE Other / unclassified 1.25 % Other
Comparator ISOXAFLUTOLE Other / unclassified 2.3 % Other
Comparator ISOXAFLUTOLE Other / unclassified 4.5 % Other
Comparator Physioneal Unknown 1.36 % Other
Comparator Physioneal Unknown 2.27 % Other
Comparator Physioneal Unknown 3.86 % Other
Subject XyloCore Unknown 0.7 % Other
Subject XyloCore Unknown 1.5 % Other
Subject XyloCore Unknown 2 % Other

Indications

end stage renal failure