Condition category
Urological and Genital Diseases
Date applied
08/09/2004
Date assigned
19/10/2004
Last edited
20/09/2007
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 Bruce Culleton

ORCID ID

Contact details

Foothills Hospital
1403-29th ST NW
Calgary
T2N 2T9
Canada
+1 403 944 8166
bruce.culleton@calgaryhealthregion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Nocturnal haemodialysis and conventional three times per week haemodialysis will not differ with respect to progression of LV mass (measured using Cardiac Magnetic Resonance [CMR]) at 6 months.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

End-stage kidney disease

Intervention

Subjects are randomised to nocturnal haemodialysis or conventional three times per week haemodialysis (controls).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in left ventricular mass (measured by CMR) at 6 months.

Secondary outcome measures

1. Mean change in systolic Blood Pressure (BP)
2. Change in HRQOL (Health-Related Quality-Of-Life)
3. Mean change in Haematocrit (Hct)/Erythropoietin (Epo) ratio
4. Mean change in calcium - phosphorus product

Overall trial start date

01/08/2004

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All adult haemodialysis patients in Alberta, Canada are eligible.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

38 subjects

Participant exclusion criteria

Patients who are unable to perform NHD due to physical or mental incapacity.

Recruitment start date

01/08/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Foothills Hospital
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

Kidney Foundation of Canada (Canada)

Sponsor details

300-5165 Sherbrooke ST W
Montreal
Quebec
H4A 1T6
Canada
research@kidney.ca

Sponsor type

Research organisation

Website

http://www.kidney.ca/

Funders

Funder type

Research organisation

Funder name

Kidney Foundation of Canada (Canada)

Alternative name(s)

La Fondation canadienne du rein, KFOC

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Canada

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17878421

Publication citations

  1. Results

    Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ, Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial., JAMA, 2007, 298, 11, 1291-1299, doi: 10.1001/jama.298.11.1291.

Additional files

Editorial Notes