Peritoneal DialysisPhase 4NCT00397358
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients
A Phase 4 study testing Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution in people with Peritoneal Dialysis and Hypertriglyceridemia, run by Vantive Health LLC at 3 sites in United States.
Trial summary
This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Hypertriglyceridemia
- What is being tested?
- Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2006to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- CAPD/APD on dialysis for at least 3 months
- Elevated fasting triglyceride levels
Who cannot join
- enrolled in another study requiring IRB approval
- allergy to starch-based polymers
- glycogen storage disease
- maltose or isomaltose intolerance
- active alcohol/substance abuse
- Pregnant or nursing
- received an investigational drug within 30 days of screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dialysis Center of Lincoln
Lincoln, Nebraska, 68510
Nephrology Specialists
Michigan City, Indiana, 46360
Kaiser Santa Clara - Homestead
Santa Clara, California, 95051
About this study
Official title: Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients
This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
Read the detailed description
This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.
- Conditions
- Peritoneal Dialysis, Hypertriglyceridemia
- Being tested
- Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution
- Keywords
- Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraneal (7.5% icodextrin) Peritoneal Dialysis SolutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fasting triglyceride levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Baxter Healthcare Corporation, Study director, Call central contact for information
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397358
- Sponsor's protocol ID
- 31656
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2006
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
PubMed 10911641Bredie SJ, Bosch FH, Demacker PN, Stalenhoef AF, van Leusen R. Effects of peritoneal dialysis with an overnight icodextrin dwell on parameters of glucose and lipid metabolism. Perit Dial Int. 2001 May-Jun;21(3):275-81.
PubMed 11475343Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.
PubMed 15980620Kronenberg F, Lingenhel A, Neyer U, Lhotta K, Konig P, Auinger M, Wiesholzer M, Andersson H, Dieplinger H. Prevalence of dyslipidemic risk factors in hemodialysis and CAPD patients. Kidney Int Suppl. 2003 May;(84):S113-6. doi: 10.1046/j.1523-1755.63.s84.23.x.
PubMed 12694323Amici G, Orrasch M, Da Rin G, Bocci C. Hyperinsulinism reduction associated with icodextrin treatment in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2001;17:80-3.
PubMed 11510303Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.
PubMed 16221697
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00397358
- Acronym / sponsor ID
- 31656
- Conditions
- Peritoneal Dialysis, Hypertriglyceridemia
- Keywords
- Peritoneal Dialysis, Hypertriglyceridemia, Extraneal(7.5% icodextrin)Peritoneal Dialysis Solution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Nov 2006 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Nov 2006 (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.
This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.
Detailed description
This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- CAPD/APD on dialysis for at least 3 months
- Elevated fasting triglyceride levels
Key exclusion criteria (7 listed)
- enrolled in another study requiring IRB approval
- allergy to starch-based polymers
- glycogen storage disease
- maltose or isomaltose intolerance
- active alcohol/substance abuse
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 (7.5% icodextrin) Peritoneal Dialysis Solution | Drug | – |
Primary outcome
Change from baseline in fasting triglyceride levels.
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 3 Mar 2025.
- Background: PubMed 10911641Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
- Background: PubMed 11475343Bredie SJ, Bosch FH, Demacker PN, Stalenhoef AF, van Leusen R. Effects of peritoneal dialysis with an overnight icodextrin dwell on parameters of glucose and lipid metabolism. Perit Dial Int. 2001 May-Jun;21(3):275-81.
- Background: PubMed 15980620Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. doi: 10.1159/000086553. Epub 2005 Jun 23.
- Background: PubMed 12694323Kronenberg F, Lingenhel A, Neyer U, Lhotta K, Konig P, Auinger M, Wiesholzer M, Andersson H, Dieplinger H. Prevalence of dyslipidemic risk factors in hemodialysis and CAPD patients. Kidney Int Suppl. 2003 May;(84):S113-6. doi: 10.1046/j.1523-1755.63.s84.23.x.
- Background: PubMed 11510303Amici G, Orrasch M, Da Rin G, Bocci C. Hyperinsulinism reduction associated with icodextrin treatment in continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2001;17:80-3.
- Background: PubMed 16221697Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. doi: 10.1093/ndt/gfi197. Epub 2005 Oct 12.
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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.
Baxter Healthcare Corporation study director
Call central contact for information
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution in people with Peritoneal Dialysis and Hypertriglyceridemia, run by Vantive Health LLC at 3 sites in United States.
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 7 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 3 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 3 sites in United States. 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?
Change from baseline in fasting triglyceride levels.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397358, which also lists 6 linked publications.
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 3 Mar 2025.