Peritoneal Dialysis Versus Haemodialysis | NCT00752583

Studies
Peritoneal Dialysis Versus Haemodialysis

NCT00752583

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 15, 2022Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

Peritoneal dialysis
Haemodialysis

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

Dec 2022

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

Nov 7, 2008Actual

Primary Completion Date

Nov 30, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Sep 12, 2008

First Submission Date that Met QC Criteria

Sep 12, 2008

First Posted Date

Sep 15, 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

Dec 14, 2022

Last Update Posted Date

Dec 15, 2022Actual

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

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Peritoneal dialysis	Procedure: Peritoneal dialysis
2	Active Comparator	Haemodialysis	Procedure: Haemodialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peritoneal dialysis	Procedure	Blood, urine and dialysate sampling	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Registration of toxin removal efficiency		After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).

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
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
D003956	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