Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/01/2006
Date assigned
02/02/2006
Last edited
13/06/2016
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 Paul Tam

ORCID ID

Contact details

78 Corporate Drive
Unit number 10
Scarborough
M1H 3G4
Canada
+1 (0)416 279 0855
pywtam@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of low glucose degradation product peritoneal dialysis solution Gambrosol-Trio on residual renal function in patients receiving peritoneal dialysis - a randomized controlled trial

Acronym

Study hypothesis

That the use of a peritoneal dialysis solution with low concentrations of Glucose Degradation Products (GDP) will reduce the rate of residual renal function decline in patients receiving peritoneal dialysis

Ethics approval

1. Scarborough Hospital Ethics Review Board, 27/07/2005, ref: NEPH-27
2. Credit Valley Ethics Review Board, 21/09/2005, ref: KW/EX/05-078
3. The Princess Margaret Hospital Ethics Review Board, 16/06/2005

Study design

Randomized (by the minimization method) controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

End stage renal failure

Intervention

Usual (standard) peritoneal dialysis solution versus peritoneal dialysis solution with low glucose degradation products

Intervention type

Drug

Phase

Not Applicable

Drug names

Gambrosol-Trio

Primary outcome measures

Rate of decline of residual renal function

Secondary outcome measures

1. Peritoneal ultrafiltration
2. Peritonitis episodes
3. Cardiovascular events (combination of non-fatal myocardial infarction [MI], peripheral vascular disease requiring lower limb amputation, strokes, and deaths due to cardiovascular causes)
4. Peritoneal equilibration test results
5. Peritoneal clearances of urea and creatinine
6. Changes in dialysate CA125 and advanced glycosylated end products

Overall trial start date

01/07/2005

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or above
2. Able to give consent
3. Patient with Peritoneal Dialysis (PD) catheter inserted

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98 patients in total from three sites

Participant exclusion criteria

1. Age less than 18
2. Previous hemodialysis
3. Those unlikely to continue peritoneal dialysis for more than six months due to severe comorbid conditions, planned living renal transplantation, or planned transfer to another facility
4. Patients with previous renal transplant
5. Patients starting incremental peritoneal dialysis
6. 24-hour urine volume of less than 100 ml and/or creatinine clearance of less than 1 ml/min
7. Patients with psychiatric diagnoses that might impinge on compliance

Recruitment start date

01/07/2005

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Canada, China

Trial participating centre

Scarborough General Hospital
Scarborough
-
Canada

Trial participating centre

Credit Valley Hospital
Mississaugua
-
Canada

Trial participating centre

Princess Margaret Hospital
Hong Kong
-
China

Sponsor information

Organisation

Institute of Kidney Lifescience Technologies (Canada)

Sponsor details

78 Corporate Drive
Unit number 10
Scarborough
M1H 3G4
Canada
+1 (0)416 279 0855
pywtam@yahoo.com

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Gambro, Hong Kong will provide support for measurement of samples and data collection at the Hong Kong site.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Institute of Kidney Lifescience Technologies, a non-profit organization based in Scarborough, Canada will fund all other aspects of the study.

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27282852

Publication citations

Additional files

Editorial Notes

13/06/2016: Publication reference added.