The Interrelation of the Vasculature, Endothelium, Bone M... | NCT00433264

Studies
The Interrelation of the Vasculature, Endothelium, Bone Metabolism and Uremic Toxins in Peritoneal Dialysis

NCT00433264

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Mar 5, 2009Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Chronic Kidney Disease

Interventions

peritoneal dialysis

Countries

Belgium

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 7, 2007

First Submission Date that Met QC Criteria

Feb 7, 2007

First Posted Date

Feb 9, 2007Estimated

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

Mar 4, 2009

Last Update Posted Date

Mar 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Despite major advances in the treatment of chronic kidney disease, the age and sex matched mortality far exceeds that of the normal population. As in the normal population, the majority of deaths are related to cardiovascular disease. Mounting data point to the lethal synergy between chronic kidney disease and cardiovascular disease. This relation is present from early stages of chronic kidney disease on.

Several uremic toxins have been demonstrated to play an important role in kidney disease related endothelial dysfunction. In peritoneal dialysis patients, data on the relation between uremic toxins, endothelial dysfunction and microparticles are lacking.

The investigators hypothesize that endothelial dysfunction and uremic toxins are interrelated in peritoneal dialysis patients

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Name	Type	Description	Arm Group Labels	Other Names
peritoneal dialysis	Procedure	individualised		individualised

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18
Maintenance peritoneal dialysis

Exclusion Criteria:

No informed consent
Peritonitis

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

Tertiary referral center university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjorn Meijers, MD	UZ Leuven	Principal Investigator
Kathleen Claes, MD	UZ Leuven	Principal Investigator
Pieter Evenepoel, MD, PhD	UZ Leuven	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaire Ziekenhuizen Leuven		Leuven	Vlaams-Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010530	Peritoneal Dialysis

Ancestor Terms

ID	Term
D006435	Renal Dialysis
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification

Browse Leaves

Not provided

Browse Branches

Not provided