NCT00851838

L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

Phase 2 Study of Dialysis Efficiency and Tolerability of Peritoneal Dialysis Solution Containing Glucose Plus L-Carnitine in APD (Automated Peritoneal Dialysis) Treated Uremic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (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 L-carnitine as an osmotic agent to partially replace glucose.

Conditions

• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	L-Carnitine	Instillation of glucose-based (1.5 or 2.5 w/v) PD solution containing L-carnitine during the nocturnal exchange in APD treated patients. L-Carnitine (0.1% w/v) is present only in the first 5 Liter APD bag. PD solutions are instilled for 5 days.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2009-02-26
• Last updated: 2019-06-25

Locations

1 site across 1 country: Italy