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

ISRCTN	ISRCTN26252543
DOI	https://doi.org/10.1186/ISRCTN26252543
Protocol serial number	N/A
Sponsor	Institute of Kidney Lifescience Technologies (Canada)
Funders	Gambro, Hong Kong will provide support for measurement of samples and data collection at the Hong Kong site., The Institute of Kidney Lifescience Technologies, a non-profit organization based in Scarborough, Canada will fund all other aspects of the study.

Submission date: 18/01/2006
Registration date: 02/02/2006
Last edited: 13/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Tam
Scientific

78 Corporate Drive
Unit number 10
Scarborough
M1H 3G4
Canada

Phone	+1 (0)416 279 0855
Email	pywtam@yahoo.com

Study information

Primary study design	Interventional
Study design	Randomized (by the minimization method) controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Gambrosol-Trio
Primary outcome measure(s)	Rate of decline of residual renal function
Key secondary outcome measure(s)	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
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	98
Key inclusion criteria	1. Age 18 years or above 2. Able to give consent 3. Patient with Peritoneal Dialysis (PD) catheter inserted
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Canada
China

Study participating centres

Scarborough General Hospital

Scarborough
-
Canada

Credit Valley Hospital

Mississaugua
-
Canada

Princess Margaret Hospital

Hong Kong
-
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/06/2016: Publication reference added.