Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1422
Study information
Scientific title
Acronym
Study hypothesis
To collect data to support European Conformity (CE)-marking of product.
Ethics approval
Ethics Committee in Brussels and Ethics Committee in Lyon, approval pending as of 20/11/2006.
Study design
Open, multicentre, prospective non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic renal failure
Intervention
1. Investigational product: HEP-AN69ST
2. Control product: AN69AT
This is a non-randomised study. All patients will have the following treatments:
Week one: Three treatments with AN69ST (with usual heparin dose in the ECC)
Week two: Three treatments with HEP-AN69ST with the same heparin dose in the ECC as in week one
Week three: Three treatments with HEP-AN69ST with a 50% decrease in the heparin dose compared with weeks one and two
Intervention type
Drug
Phase
Not Specified
Drug names
Heparin
Primary outcome measure
Adverse events, particularly related to bleeding and premature clotting
Secondary outcome measures
1. Questionnaire to hospital staff regarding priming procedure
2. Dialysance-easurement
3. Rinse back evaluations
Overall trial start date
15/12/2006
Overall trial end date
30/04/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients suffering from chronic renal failure
2. Patients treated in Haemodialysis (HD) unit performed with or without heparin injection in the Extra Corporeal Circuit (ECC)
3. Patients treated three times a week with AN69ST for a minimum of one month
4. Patients 18 years or older
5. Patients with a well-functioning vascular access as judged by the investigator
6. Signed written informed consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
1. Patients with known allergy to heparin
2. Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients
3. Pregnant women, nursing mothers and women planning a pregnancy during the course of the study
4. Patients under guardianship
5. Patients participating in other studies that could interfere with the objectives of this study
6. Patients treated in single needle mode
7. Patients treated in HD with low molecular weight heparin injection in the ECC
8. Patients with catheter
Recruitment start date
15/12/2006
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Belgium, France
Trial participating centre
Clinical Affairs
Lund
220 10
Sweden
Sponsor information
Organisation
Gambro Industries (France)
Sponsor details
Clinical Affairs
61 avenue Tony Garnier
Lyon
FR-69357
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro Industries (France)
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