NCT00858182

Study of Safety and Efficacy on New Peritoneal Dialysis Solutions

Evaluation of a New Peritoneal Dialysis Solutions Containing Glucose, Xylitol and L-carnitine Compared to Standard PD Solutions in End-stage Renal Disease (ESRD) Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Iperboreal Pharma Srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.

Conditions

• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	PD solution for nocturnal exchanges	Instillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks.
DRUG	PD solution for diurnal exchanges	Instillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2009-03-09
• Last updated: 2019-06-26