Condition category
Urological and Genital Diseases
Date applied
17/03/2006
Date assigned
24/03/2006
Last edited
24/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christian Combe

ORCID ID

Contact details

Hôpital Pellegrin
Service de Néphrologie
Place Amélie Raba-Léon
Bordeaux
33076
France
christian.combe@chu-bordeaux.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

POL-FRA-1

Study information

Scientific title

Acronym

INFLUX

Study hypothesis

The aim of the study is to evaluate the influence of dialysis membrane permeability on biological parameters that predict morbidity and mortality of hemodialysis patients with moderate chronic inflammation

Ethics approval

Consulting committee for the protection of people in biomedical research, Bordeaux A (Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale [CCPPRB] de Bordeaux A) - number 2004/49, June 18, 2004.

Study design

Prospective, multicenter, randomised

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

End-stage renal disease

Intervention

Hemodialysis treatment with high-flux versus low-flux dialysers of the same type of chemical composition

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Plasma concentration of C-reactive protein

Secondary outcome measures

Advanced glycation end products, carboxymethyl lysine, asymmetric dimethyl arginine, fibrinogen, albumin and prealbumin, phosphate

Overall trial start date

10/02/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Medically stable end-stage renal disease patients on hemodialysis for 6 months or more
2. Age ≥18 years
3. C-reactive protein between 5 and 50 mg/l maximum one week before inclusion
4. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) serologies negative
5. Not under guardianship
6. AgHbs negative
7. Absence of vascular access thrombosis
8. Absence of clinically identifiable cause of chronic inflammation
9. Treatment in a dialysis unit providing water quality according to the European Pharmacopoeia
10. Statin medication allowed, but no introduction or modification during the study
11. Hemodialysis blood flow rates between 200 and 500 ml/min possible
12. Dialysis frequency 3-4 per week

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Age >75 years
2. Known pregnancy
3. Severe comorbidities with life expectancy <1 year
4. Cancer except skin cancer
5. Severe digestive pathologies
6. Chronic inflammatory diseases
7. Medication interfering with nutritional or inflammatory status
8. Treatment or intention to treat with immunosuppressive medication
9. Dialysis dose Kt/V <1.2, and dialysis time <10 hours per week
10. Treatment with hemofiltration or hemodiafiltration
11. Participation in another study during the preceding 30 days
12. Physically or mentally disabled patients

Recruitment start date

10/02/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

France

Trial participating centre

Hôpital Pellegrin
Bordeaux
33076
France

Sponsor information

Organisation

Gambro SAS (France)

Sponsor details

1-3
Boulevard Charles-de-Gaulle
Colombes
92707
France
georges.martin@gambro.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gambro SAS

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes