Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr M.P.C. Grooteman
ORCID ID
Contact details
Vrije University Medical Centre (VUMC)
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2673
mpc.grooteman@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00205556
Protocol/serial number
NTR24
Study information
Scientific title
Effect of increased convective clearance by on-line haemodiafiltration on all cause and cardiovascular mortality in chronic haemodialysis patients: the Dutch CONvective TRAnsport STudy
Acronym
CONTRAST
Study hypothesis
The high incidence of cardiovascular disease in patients with End Stage Renal Disease (ESRD) is related with the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online Haemodiafiltration (HDF) lowers these molecules more effectively than standard Haemodialysis (HD), it is suggested that this treatment may improve cardiovascular outcome.
On 24/01/2008 the following changes were made to the trial record:
1. The anticipated end date was changed from 31/12/2009 to 31/12/2010.
2. The target number of participants was changed from 800 to 700.
Ethics approval
The Medical Ethics Review Committee of the Vrije Universiteit Medical Center in Amsterdam, the Netherlands. Approved on 31/07/2003, ref: 2003/97. Amendment to protocol approved on 28/06/2007.
Study design
Multicentre randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic haemodialysis (HD)
Intervention
Patients will be randomised between:
1. Online haemodiafiltration
2. (Continuation with) low-flux haemodialysis
Added 24/01/2008:
Follow up: Variable follow-up period of 1-7 years (in previous version of protocol: fixed follow up of 3 years)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Cardiovascular morbidity and mortality. This is a composite endpoint comprising fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). Also all-cause mortality is considered a primary endpoint.
Secondary outcome measures
Current secondary outcome measures as of 20/01/2011:
Changes in:
1. Carotid Intima Media Thickness (cIMT)
2. Aortic Pulse Wave Velocity (PWV)
3. Left Ventricular Mass index (LVMi)
4. Interdialytic blood pressure
5. Laboratory assessments (oxidative stress; acute phase response; lipid profile; various)
6. Quality of life
7. Nutritional state
8. Anemia management: hemoglobin levels and erythropoietin use/resistance (addendum to the protocol on this issue has been approved by ethical committee in October, 2003)
9. Cost utility analysis (addendum to the protocol on this issue has been approved by the ethical committee in April, 2008)
10. Hospitalization days
11. Hospital admission for infection
12. Hospital admission for any cause
13. Blood pressure and antihypertensive medication
14. Residual kidney function
15. Laboratory parameters on mineral bone disease and medication
16. Treatment delivery (dialysis efficiency Kt/V urea, ultrafiltration volume, and only HDF: convection volume)
Previous secondary outcome measures:
Changes in:
1. Carotid Intima Media Thickness (cIMT)
2. Aortic Pulse Wave Velocity (PWV)
3. Left Ventricular Mass index (LVMi)
4. Interdialytic blood pressure
5. Laboratory assessments (oxidative stress; acute phase response; lipid profile; various)
6. Quality of life
7. Nutritional state
Overall trial start date
01/06/2004
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients treated by HD 2 or 3 times a week, for at least 2 months
2. Patients able to understand the study procedures
3. Patients willing to provide written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Participant exclusion criteria
1. Current age less than 18 years treatment by Haemodiafiltration (HDF) or high flux HD in the preceding 6 months
2. Severe incompliance life expectancy less than 3 months due to non-renal disease
3. Participation to other clinical intervention trials evaluating cardiovascular outcome
Recruitment start date
01/06/2004
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2673
mpc.grooteman@vumc.nl
Sponsor type
University/education
Website
Organisation
University Medical Center Utrecht (UMCU) (The Netherlands)
Sponsor details
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands) (ref: C02.2019)
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
Funder name
Fresenius Medical Care (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gambro (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dr E.E. Twiss Fund (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche (The Netherlands)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
The International Society of Nephrology (The Netherlands) - Baxter Extramural Grant Program
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
1. Protocol in:
1.1. http://www.ncbi.nlm.nih.gov/pubmed/15663765
1.2. http://www.ncbi.nlm.nih.gov/pubmed/15907201
2. Review (this trial mentioned) in: http://www.ncbi.nlm.nih.gov/pubmed/18045819
3. Interim report: http://www.ncbi.nlm.nih.gov/entrez/pubmed/16886698
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23124783
5. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24458074
6. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24505249
7. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24408114
Publication citations
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Results
Mazairac AH, de Wit GA, Grooteman MP, Penne EL, van der Weerd NC, den Hoedt CH, Lévesque R, van den Dorpel MA, Nubé MJ, ter Wee PM, Bots ML, Blankestijn PJ, , Effect of hemodiafiltration on quality of life over time., Clin J Am Soc Nephrol, 2013, 8, 1, 82-89, doi: 10.2215/CJN.00010112.
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Results
den Hoedt CH, Bots ML, Grooteman MP, van der Weerd NC, Penne EL, Mazairac AH, Levesque R, Blankestijn PJ, Nubé MJ, ter Wee PM, van den Dorpel MA, , Clinical predictors of decline in nutritional parameters over time in ESRD., Clin J Am Soc Nephrol, 2014, 9, 2, 318-325, doi: 10.2215/CJN.04470413.
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Results
Mostovaya IM, Bots ML, van den Dorpel MA, Goldschmeding R, den Hoedt CH, Kamp O, Levesque R, Mazairac AH, Penne EL, Swinkels DW, van der Weerd NC, Ter Wee PM, Nubé MJ, Blankestijn PJ, Grooteman MP, Left ventricular mass in dialysis patients, determinants and relation with outcome. Results from the COnvective TRansport STudy (CONTRAST)., PLoS ONE, 2014, 9, 2, e84587, doi: 10.1371/journal.pone.0084587.
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Results
Mostovaya IM, Bots ML, van den Dorpel MA, Grooteman MP, Kamp O, Levesque R, Ter Wee PM, Nubé MJ, Blankestijn PJ, A randomized trial of hemodiafiltration and change in cardiovascular parameters., Clin J Am Soc Nephrol, 2014, 9, 3, 520-526, doi: 10.2215/CJN.07140713.
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Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nubé MJ, ter Wee PM, , Resolving controversies regarding hemodiafiltration versus hemodialysis: the Dutch Convective Transport Study., Semin Dial, 18, 1, 47-51, doi: 10.1111/j.1525-139X.2005.18107.x.
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Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nubé MJ, van der Tweel I, Ter Wee PM, , Effect of increased convective clearance by on-line hemodiafiltration on all cause and cardiovascular mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial [ISRCTN38365125]., Curr Control Trials Cardiovasc Med, 2005, 6, 1, 8, doi: 10.1186/1468-6708-6-8.
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van der Weerd NC, Penne EL, van den Dorpel MA, Grooteman MP, Nube MJ, Bots ML, ter Wee PM, Blankestijn PJ, Haemodiafiltration: promise for the future?, Nephrol. Dial. Transplant., 2008, 23, 2, 438-443, doi: 10.1093/ndt/gfm791.