End Stage Renal DiseaseNCT02166359
Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
A study testing Extraneal (Icodextrin) and Glucose solution in people with End Stage Renal Disease, run by Dong-A University at 1 site in South Korea.
Trial summary
Patients with chronic kidney disease (CKD) have a markedly higher prevalence of cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major cause of CVD in patients with CKD. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Extraneal (Icodextrin) and Glucose solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Apr 2019
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD patients agree with written informed consent
- Incident and prevalent PD patients on dialysis for at least 3month
- PD patients treated with two glucose solutions including 2.5% or 4.25% dextrose solution at least 4hour
Who cannot join
- PD patients with allergy to starch-based polymers
- PD patients with glycogen storage disease
- PD patients with maltose or isomaltose intolerance
- PD patients with active alcohol/substance abuse
- Pregnant or nursing PD patients
- PD patients with an episode of peritonitis and active systemic infection within 4weeks before study initiation
Show all 11Show fewer
- PD patients newly prescribed with lipid-lowering medications, including statins, omega-3 fatty acids or sevelamer hydrochloride within 3 months before randomization
- PD patients with triglyceride level> 500 mg/dL/L or <100 mg/dL
- PD patients with albumin level < 3.0 gram/dL
- PD patients treated with automated PD
- PD patients had been treated or are treating with icodextrin PD solutions
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic kidney disease (CKD) have a markedly higher prevalence of cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use of glucose as the osmotic agent in PD solutions has been associated with a variety of metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD patients. A study showed that patients with high triglyceride levels were more insulin-resistant than those with normal triglyceride levels.
Insulin resistant is associated with atherogenic response represented high plasma levels of monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high triglyceride level may play an important role to CV outcome of PD patients. PD solution decreasing triglyceride levels is essential in PD patients.
Read more
Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of icodextrin, which is catabolized into maltose, considerably reduces caloric uptake. Therefore, icodextrin may have an additional favorable effect on triglyceride level.
There are several studies regarding the effect of icodextrin on triglyceride level in PD patients. However, the outcomes are controversial, some studies showed no association between icodextrin and triglyceride change, even the others showed positive results but these also have study design limitations such as non-randomized study or secondary primary outcome. It is not clear about the effect of icodextrin on triglyceride especially in PD patients without diabetes.
The investigators therefore want to conduct a randomized, cross-over, controlled multicenter trial comparing icodextrin solution and glucose solution in PD patients with and without diabetes, focusing on triglyceride change.
- Conditions
- End Stage Renal Disease
- Being tested
- Extraneal (Icodextrin), Glucose solution
- Keywords
- Icodextrin, Triglyceride
- 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.
Extraneal (Icodextrin)Drug
Also called Extraneal, Icodextrin
Glucose solutionDrug
Also called 2.5% dextrose solution, 4.25% dextrose solution
| Study group | Role | What they receive |
|---|---|---|
| Glucose group | Active comparator | Glucose use of 2.5% or 4.25% dextrose solution at least 4 hours Receives: Drug: Glucose solution |
| Extraneal (Icodextrin) group | Experimental | Extraneal (Icodextrin) use at least 8 hours Receives: Drug: Extraneal (Icodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference and change of triglyceride levels after follow up between 2 groups
The difference and change of triglyceride after follow up between 2 groups (glucose group with diabetes (n=20) vs. icodextrin group with diabetes (n=20) and glucose group without diabetes (n=20) vs. icodextrin group without diabetes (n=20) )
Measured: baseline and 3 months after intervention
Secondary outcomes (4)
The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content
Measured: baseline and 3 months after intervention
The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B
Measured: baseline and 3 months after intervention
The mean difference and change of blood glucose level, insulin and HbA1c
Measured: baseline and 3 months after intervention
The mean difference and change of ultrafiltration volume
Measured: baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2019
- Study completionApr 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, WON SUK AN, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166359
- Sponsor's protocol ID
- EXIT study
- Status last verified
- May 2019
- First submitted
- 14 Jun 2014
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extraneal (Icodextrin) on Triglyceride Levels in PD Patients
- ClinicalTrials.gov ID
- NCT02166359
- Acronym / sponsor ID
- EXIT study
- Conditions
- End Stage Renal Disease
- Keywords
- Icodextrin, Triglyceride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2014
- Primary completion
- Mar 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Jun 2014 (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.
Patients with chronic kidney disease (CKD) have a markedly higher prevalence of cardiovascular disease (CVD) than the general population. Dyslipidemia is considered a major cause of CVD in patients with CKD. Especially for peritoneal dialysis (PD) patients, the use of glucose as the osmotic agent in PD solutions has been associated with a variety of metabolic consequences ranging from acute hyperglycemia and hyperinsulinemia to dyslipidemia and weight gain. Among lipid abnormalities, hypertriglyceridemia is the most common in PD patients. A study showed that patients with high triglyceride levels were more insulin-resistant than those with normal triglyceride levels.
Insulin resistant is associated with atherogenic response represented high plasma levels of monocyte chemotactic protein-1 in a large cohort of dialysis patients. Therefore, high triglyceride level may play an important role to CV outcome of PD patients. PD solution decreasing triglyceride levels is essential in PD patients.
Icodextrin, a starch-derived high molecular weight glucose polymer was found to increase ultrafiltration compared to glucose solutions. Furthermore, a low peritoneal absorption of icodextrin, which is catabolized into maltose, considerably reduces caloric uptake. Therefore, icodextrin may have an additional favorable effect on triglyceride level.
There are several studies regarding the effect of icodextrin on triglyceride level in PD patients. However, the outcomes are controversial, some studies showed no association between icodextrin and triglyceride change, even the others showed positive results but these also have study design limitations such as non-randomized study or secondary primary outcome. It is not clear about the effect of icodextrin on triglyceride especially in PD patients without diabetes.
The investigators therefore want to conduct a randomized, cross-over, controlled multicenter trial comparing icodextrin solution and glucose solution in PD patients with and without diabetes, focusing on triglyceride change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose group | Active comparator | Drug: Glucose solutionGlucose use of 2.5% or 4.25% dextrose solution at least 4 hours |
| Extraneal (Icodextrin) group | Experimental | Drug: Extraneal (Icodextrin)Extraneal (Icodextrin) use at least 8 hours |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PD patients agree with written informed consent
- Incident and prevalent PD patients on dialysis for at least 3month
- PD patients treated with two glucose solutions including 2.5% or 4.25% dextrose solution at least 4hour
Key exclusion criteria (11 listed)
- PD patients with allergy to starch-based polymers
- PD patients with glycogen storage disease
- PD patients with maltose or isomaltose intolerance
- PD patients with active alcohol/substance abuse
- Pregnant or nursing PD patients
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 |
|---|---|---|
| Extraneal (Icodextrin)Also: Extraneal, Icodextrin | Drug | Extraneal (Icodextrin) group |
| Glucose solutionAlso: 2.5% dextrose solution, 4.25% dextrose solution | Drug | Glucose group |
Primary outcome
The mean difference and change of triglyceride levels after follow up between 2 groups
Time frame: baseline and 3 months after intervention
The difference and change of triglyceride after follow up between 2 groups (glucose group with diabetes (n=20) vs. icodextrin group with diabetes (n=20) and glucose group without diabetes (n=20) vs. icodextrin group without diabetes (n=20) )
4 secondary outcomes
The mean difference and change of erythrocyte membrane monounsaturated fatty acid content and oleic acid content
Time frame: baseline and 3 months after intervention
The mean difference and change of total cholesterol , LDL, HDL, very low-density lipoprotein, apolipoprotein A and apolipoprotein B
Time frame: baseline and 3 months after intervention
The mean difference and change of blood glucose level, insulin and HbA1c
Time frame: baseline and 3 months after intervention
The mean difference and change of ultrafiltration volume
Time frame: baseline and 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraneal (Icodextrin) and Glucose solution in people with End Stage Renal Disease, run by Dong-A University at 1 site in South Korea.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 29 May 2019. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The mean difference and change of triglyceride levels after follow up between 2 groups (time frame: baseline and 3 months after intervention). 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 29 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.