NCT00397358

Brief Summary

This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

November 7, 2006

Last Update Submit

February 26, 2025

Conditions

Peritoneal DialysisHypertriglyceridemia

Keywords

Peritoneal DialysisHypertriglyceridemiaExtraneal(7.5% icodextrin)Peritoneal Dialysis Solution

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in fasting triglyceride levels.

Interventions

Extraneal (7.5% icodextrin) Peritoneal Dialysis SolutionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • CAPD/APD on dialysis for at least 3 months
  • Elevated fasting triglyceride levels

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Santa Clara - Homestead

Santa Clara, California, 95051, United States

Location

Nephrology Specialists

Michigan City, Indiana, 46360, United States

Location

Dialysis Center of Lincoln

Lincoln, Nebraska, 68510, United States

Location

Related Publications (6)

  • Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.

    PMID: 10911641BACKGROUND

  • Bredie 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.

    PMID: 11475343BACKGROUND

  • Martikainen 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.

    PMID: 15980620BACKGROUND

  • Kronenberg 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.

    PMID: 12694323BACKGROUND

  • Amici 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.

    PMID: 11510303BACKGROUND

  • Furuya 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.

    PMID: 16221697BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

IcodextrinDialysis Solutions

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Baxter Healthcare Corporation

    Call central contact for information

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations

US(3)