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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Paul Tam
Scientific
Scientific
78 Corporate Drive
Unit number 10
Scarborough
M1H 3G4
Canada
| Phone | +1 (0)416 279 0855 |
|---|---|
| pywtam@yahoo.com |
Study information
| Study design | Randomized (by the minimization method) controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 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(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 |
| Condition | End stage renal failure |
| Intervention | Usual (standard) peritoneal dialysis solution versus peritoneal dialysis solution with low glucose degradation products |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gambrosol-Trio |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Overall study end date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 98 patients in total from three sites |
| Participant inclusion criteria | 1. Age 18 years or above 2. Able to give consent 3. Patient with Peritoneal Dialysis (PD) catheter inserted |
| 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
Study participating centres
Scarborough General Hospital
Scarborough
-
Canada
-
Canada
Credit Valley Hospital
Mississaugua
-
Canada
-
Canada
Princess Margaret Hospital
Hong Kong
-
China
-
China
Sponsor information
Institute of Kidney Lifescience Technologies (Canada)
Research organisation
Research organisation
78 Corporate Drive
Unit number 10
Scarborough
M1H 3G4
Canada
| Phone | +1 (0)416 279 0855 |
|---|---|
| pywtam@yahoo.com | |
"ROR" |
https://ror.org/05vhw2a70 |
Funders
Funder type
Industry
Gambro, Hong Kong will provide support for measurement of samples and data collection at the Hong Kong site.
No information available
The Institute of Kidney Lifescience Technologies, a non-profit organization based in Scarborough, Canada will fund all other aspects of the study.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
13/06/2016: Publication reference added.
