Removal of Uremic Toxins With Nocturnal Dialysis Versus S... | NCT00766792

Studies
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis

NCT00766792

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Oct 31, 2008Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Chronic Renal Failure

Interventions

Nocturnal dialysis
Standard 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

Oct 2008

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

Dec 2005

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 3, 2008

First Posted Date

Oct 6, 2008Estimated

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

Oct 30, 2008

Last Update Posted Date

Oct 31, 2008Estimated

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

Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Nocturnal dialysis	Procedure: Nocturnal dialysis
2	Active Comparator	Standard dialysis	Procedure: Standard dialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nocturnal dialysis	Procedure	Switch to nocturnal dialysis (3 times 480 min/week)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate what is more effective for removal of uremic toxins - nocturnal versus standard dialysis?		30 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years

Exclusion Criteria:

pregnancy

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
Raymond Vanholder, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website of the University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided