End Stage Renal DiseasePhase 4ECOSNCT01093547
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
A Phase 4 study testing Blood samples and Measure of peritoneal ultrafiltrates in people with End Stage Renal Disease and Continuous Ambulatory Peritoneal Dialysis, run by Vantive Health LLC at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis
- What is being tested?
- Blood samples and Measure of peritoneal ultrafiltrates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients
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.
- Being tested
- Blood samples, Measure of peritoneal ultrafiltrates
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
Samples taken monthly
Measure of peritoneal ultrafiltratesProcedure or surgery
Measured by the investigators intermittently and by the patients themselves on a monthly basis
| Study group | Role | What they receive |
|---|---|---|
| Dianeal only | Active comparator | Patients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange Receives: 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 Receives: Procedure: Blood samples; Procedure: Measure of peritoneal ultrafiltrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (7)
HbA1c
Measured: 12 months
Ultrafiltration of long-dwell exchange
Measured: 12 months
Blood pressure
Measured: 12 months
Quality of life
Measured: 12 months
Hospitalization rate
Measured: 12 months
Time during hospitalization
Measured: 12 months
Incidence of Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startFeb 2010 (estimated)
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Mauricio R Sanabria, M.D., Principal investigator, Baxter, RTS Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093547
- Sponsor's protocol ID
- ECOS
- Acronym
- ECOS
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2010
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Open-label, Randomized Trial to Determine the Effect of Icodextrin (Extraneal) Versus Dextrose (Dianeal 2.5%) Used in Long-dwell Exchange, Measuring the HOMA Index in Non-diabetic Prevalent CAPD Patients
- ClinicalTrials.gov ID
- NCT01093547
- Acronym / sponsor ID
- ECOS / ECOS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Feb 2010 (estimated)
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dianeal only | Active comparator | Procedure: Blood samples, Procedure: Measure of peritoneal ultrafiltratesPatients in Dianeal during the daily exchanges and randomised to Dianeal during the long-dwell exchange |
| Dianeal; Extraneal long-dwell exchange | Active comparator | Procedure: Blood samples, Procedure: Measure of peritoneal ultrafiltratesPatients in Dianeal during the daily exchanges and randomised to Extraneal during the long-dwell exchange |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesSamples taken monthly | Procedure or surgery | Dianeal only, Dianeal; Extraneal long-dwell exchange |
| Measure of peritoneal ultrafiltratesMeasured by the investigators intermittently and by the patients themselves on a monthly basis | Procedure or surgery | Dianeal only, Dianeal; Extraneal long-dwell exchange |
Primary outcome
HOMA index
Time frame: 4 months
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.
7 secondary outcomes
HbA1c
Time frame: 12 months
Ultrafiltration of long-dwell exchange
Time frame: 12 months
Blood pressure
Time frame: 12 months
Quality of life
Time frame: 12 months
Hospitalization rate
Time frame: 12 months
Time during hospitalization
Time frame: 12 months
Incidence of Adverse Events
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio R Sanabria, M.D. principal investigator
Baxter, RTS Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood samples and Measure of peritoneal ultrafiltrates in people with End Stage Renal Disease and Continuous Ambulatory Peritoneal Dialysis, run by Vantive Health LLC at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA index (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.