Effect of Extraneal (Icodextrin)on Triglyceride Levels in... | NCT00397358

Studies
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients

NCT00397358

Sponsor

Vantive Health LLC

Status

Withdrawn

Last Update Posted

Mar 3, 2025Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Peritoneal Dialysis
Hypertriglyceridemia

Interventions

Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Nov 2006Actual

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Nov 7, 2006

First Submission Date that Met QC Criteria

Nov 8, 2006

First Posted Date

Nov 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Mar 3, 2025Actual

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Extraneal (7.5% icodextrin) Peritoneal Dialysis Solution	Drug

Measure	Description	Time Frame
Change from baseline in fasting triglyceride levels.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baxter Healthcare Corporation	Call central contact for information	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Santa Clara - Homestead		Santa Clara	California	95051	United States
Nephrology Specialists

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10911641	Background	Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41.
11475343	Background	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D000077607	Icodextrin
D015314	Dialysis Solutions

ID	Term
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances