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Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR

NCT01093547 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-03-13

No results posted yet for this study

Summary

Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.

Conditions

Interventions

PROCEDURE

Blood samples

Samples taken monthly

PROCEDURE

Measure of peritoneal ultrafiltrates

Measured by the investigators intermittently and by the patients themselves on a monthly basis

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Mauricio R Sanabria, M.D. · Baxter, RTS Colombia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01093547 on ClinicalTrials.gov