NCT00375635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 12, 2006

Last Update Submit

September 12, 2006

Conditions

Uremia

Keywords

mFPSAUremic toxinsProtein bound toxinsUremiaChronic hemodialysis

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

  • Safety serological parameters

  • Concentrations of protein bound uremic toxins

Secondary Outcomes (1)

  • Bleeding episodes

Interventions

mFPSA treatmentPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18
  • Anuria
  • Chronic hemodialysis dependence

You may not qualify if:

  • No present history of bleeding episodes
  • Cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mette B Damholt, MD,Ph.d.

    Rigshospitalet P2132

    PRINCIPAL INVESTIGATOR

  • Soren D Ladefoged, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette B Damholt, MD,Ph.d.

CONTACT

+45 35453545damholt@dadlnet.dk

Soren D Ladefoged, MD

CONTACT

+45 35453545SOERENRH04736LADEFOGED@rh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

March 1, 2006

Study Completion

October 1, 2006

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

DK(1)