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

NCT01093547 | Withdrawn Phase 4

• 1 other identifier: ECOS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

End Stage Renal Disease; Continuous Ambulatory Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• HOMA index

  Measure the changes in the levels of the HOMA index when Extraneal (7.5%) is being administered in the long-dwell exchange and compare these levels to the HOMA index resulting when using Dianeal 2.5% in the long-dwell exchange in non-diabetic CAPD patients. This outcome will be evaluated by measurements taken monthly over a period of 4 months.

  4 months

Secondary Outcomes (7)

• HbA1c

  12 months

• Ultrafiltration of long-dwell exchange

  12 months

• Blood pressure

  12 months

• Quality of life

  12 months

• Hospitalization rate

  12 months

Study Arms (2)

Dianeal only

ACTIVE COMPARATOR

Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange

Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates

Dianeal; Extraneal long-dwell exchange

ACTIVE COMPARATOR

Patients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange

Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates

Interventions

Blood samples PROCEDURE

Samples taken monthly

Dianeal only; Dianeal; Extraneal long-dwell exchange

Measure of peritoneal ultrafiltrates PROCEDURE

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

Dianeal only; Dianeal; Extraneal long-dwell exchange

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be over 18-years old and under 75-years old
• Peritoneal Equilibration Test (PET) result of high, high average or low average transport
• non-diabetic patient
• be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
• prevalent patients that have been in peritoneal dialysis at least 30 days
• wish to participate

You may not qualify if:

• Have a Charlson score of \>7 and have a life expectancy of less than 12 months
• HIV positive
• present with peritonitis in the month prior to randomisation
• present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
• have active cancer
• pregnant women
• patients with known allergy to starch-based polymer
• patients who have a significant psychiatric disorder or mental disability that could interfere with the patient´s ability to provide Informed Consent and comply with the protocol procedures
• women incapable of maintaining an effective and accepted contraception method

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Unknown Facility

Bogotá, Colombia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mauricio R Sanabria, M.D.

  Baxter, RTS Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CO (1)