Removal of Protein Bound Uremic Toxins by Modified Plasma... | NCT00375635

Studies
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis

NCT00375635

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Sep 13, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Uremia

Interventions

mFPSA treatment

Countries

Denmark

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

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Sep 12, 2006

First Submission Date that Met QC Criteria

Sep 12, 2006

First Posted Date

Sep 13, 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

Sep 12, 2006

Last Update Posted Date

Sep 13, 2006Estimated

Description Module

Brief Summary

The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Detailed Description

Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

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

Name	Type	Description	Arm Group Labels	Other Names
mFPSA treatment	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure
Safety serological parameters
Concentrations of protein bound uremic toxins

Secondary Outcomes

Measure	Description	Time Frame
Bleeding episodes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over the age of 18
Anuria
Chronic hemodialysis dependence

Exclusion Criteria:

No present history of bleeding episodes
Cardiac diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mette B Damholt, MD,Ph.d.	Contact	+45 35453545	50589	damholt@dadlnet.dk
Soren D Ladefoged, MD	Contact	+45 35453545	51020	SOERENRH04736LADEFOGED@rh.dk

Overall Officials

Name	Affiliation	Role
Mette B Damholt, MD,Ph.d.	Rigshospitalet P2132	Principal Investigator
Soren D Ladefoged, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet	Recruiting	Copenhagen	Copenhagen	2200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014511	Uremia

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided