Condition category
Urological and Genital Diseases
Date applied
26/05/2005
Date assigned
15/09/2005
Last edited
14/09/2009
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

Dr Marc Dorval

ORCID ID

Contact details

330 Université
Moncton
E1C 2Z3
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CLEAN-HDF study

Study hypothesis

The CLEAN-HDF study is a randomized controlled trial comparing the performance of low-flux hemodialysis, high-flux hemodialysis and on-line hemodiafiltration with a cross over study design on a group of 48 ESRD patients using GAMBRO AK-200 Ultra generator. Research hypothesis are to demonstrate that mean % reduction of B2-microglobuline plasma concentration are superior in on-line hemodiafiltration compared to low- and high- flux hemodialysis and that the generator AK200 Ultra is capable of producing reliable sterile substitution fluid according to the European Pharmacopea

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Renal replacement therapy

Intervention

Randomised cross-over study of three hemodialysis modalities: low-flux haemodialysis, high-flux hemodialysis and on-line haemodiafiltration

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mean % reduction of B2-microglobuline plasma concentration during a mid-week session

2. Substitution fluid analysis (microbiology: culture and endotoxins and biochemical content)

Secondary outcome measures

A variety of exploratory outcomes: biochemical [for example Kt/V, total urea, creatinine of B2-microglobulin clearance, pre-post study change in b2-microglobulin concentrations, CRP, etc], dialysis tolerance, quality of life, nutritional parameters, etc).

Overall trial start date

01/06/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Chronic end-staged renal diseased (ESRD) patients on haemodialysis

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Hemodialysis for less than 3 months
2. Current or recent hospitalisation (less than 6 weeks) prior to screening period
3. Dysfunctional or infected vascular access
4. Intolerance to high-flux hemodialyser
5. Intolerance to multi-vitamin supplement
6. Severe co-morbidities limiting expected life expectance to less than 6 months
7. History of severe congestive heart failure (New York Heart Association [NYHA] class III and IV)
8. Uncontrolled hypertension (HTN) (systolic blood pressure [BP] over 200 or diastolic over 110) during the two week screening period
9. Significant and instable hypotension (systolic BP less than 90 or greater than 2 hypotension episodes/dialysis session for more than 3 sessions) during the two week screening period
10. Use of midodrine
11. Hepatite B, C or human immunodeficiency virus (HIV) positive serologies
12. Presence of pure red cell aplasia (PRCA)
13. Pregnancy or lactating
14. Current participation (or for less than 3 months) in another intervention trial
15. Presence of psychiatric, dependance or any other health problems that may compromise the hability of the subject to signed the informed consent form and/or affect compliance to the study

Recruitment start date

01/06/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Canada

Trial participating centre

330 Université
Moncton
E1C 2Z3
Canada

Sponsor information

Organisation

Beauséjour Medical Research Institute (L'Institut de Recherche Médicale Beauséjour) (IRMB) (Canada)

Sponsor details

37 Providence
Moncton
E1C 8X3
Canada

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Gambro (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nephrology Department of the Beauséjour Regional Health Authority (Canada)

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