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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list