Condition category
Urological and Genital Diseases
Date applied
13/11/2006
Date assigned
04/12/2006
Last edited
07/08/2008
Prospective/Retrospective
Prospectively 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

Mrs Kristina Hansson

ORCID ID

Contact details

Clinical Affairs
Emdalavägen 5
P.O. Box 10101
Lund
220 10
Sweden

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 measures

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

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

http://www.gambro.com/start.aspx?id=752

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes