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Study of Safety and Efficacy on New Peritoneal Dialysis Solutions

NCT00858182 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-06-26

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 xylitol and L-carnitine as osmotic agents to partially replace glucose.

Conditions

  • End-Stage Renal Disease

Interventions

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.

Sponsors & Collaborators

  • Iperboreal Pharma Srl

    lead INDUSTRY

Principal Investigators

  • Cristina Capusa, PhD · "Dr Carol Davila" University Hospital of Nephrology, Romania

  • Gabriel Mircescu, PhD · "Dr Carol Davila" University Hospital of Nephrology, Romania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-10-31
Completion
2013-01-31

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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 NCT00858182 on ClinicalTrials.gov