Survival Study in Patients Undergoing On-line Hemodiafilt... | NCT00694031

Studies
Survival Study in Patients Undergoing On-line Hemodiafiltration

NCT00694031

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

906Actual

Phase

Phase 4

Conditions

Hemodialysis

Interventions

Hemodialysis
On-line hemodiafiltration

Countries

Spain

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

Jun 2012

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

May 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 5, 2008

First Submission Date that Met QC Criteria

Jun 9, 2008

First Posted Date

Jun 10, 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

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Name	Class
Societat Catalana de Nefrologia	UNKNOWN

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

Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample size of around 750 will be necessary to detect a 35% reduction in mortality.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

906Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Hemodialysis	Procedure: Hemodialysis
B	Experimental	On-line hemodiafiltration	Procedure: On-line hemodiafiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemodialysis	Procedure	3 times per week	A
On-line hemodiafiltration

Measure	Description	Time Frame
Survival		36 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 and older
Currently undergoing hemodialysis
Clinical stability
Stable vascular access

Exclusion Criteria:

Chronic inflammatory diseases
Liver cirrhosis
Malignancies
Chronic immunosuppressant or antiinflammatory use
Dialysis through temporary catheter or single puncture

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic de Barcelona		Barcelona	Barcelona	08036	Spain
CSU Bellvitge

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20602331	Background	Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Foraster A, Soler J, Galceran JM, Martinez-Castelao A; Online Hemodiafiltration Study Group from the Catalonian Society of Nephrology. Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study. J Nephrol. 2011 Mar-Apr;24(2):196-202. doi: 10.5301/jn.2010.386.
23411788

ID	Term
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016060	Sorption Detoxification