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

NCT00851838 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-06-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Iperboreal Pharma Srl

    lead INDUSTRY

Principal Investigators

  • Mario Bonomini, MD · G. d'Annunzio University

  • Arduino Arduini, MD · Iperboreal Pharma Srl

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00851838 on ClinicalTrials.gov