Renin Angiotensin SyStem blockade: diabetes nephropathy
| ISRCTN | ISRCTN65752530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65752530 |
| ClinicalTrials.gov (NCT) | NCT00143949 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | DCT-14281 |
| Sponsor | Canadian Institutes of Health Research (CIHR) (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-14281), Merck Frosst Canada & Co (Canada) |
- Submission date
- 19/07/2004
- Registration date
- 22/07/2004
- Last edited
- 27/10/2021
- 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 Bernard Zinman
Scientific
Scientific
Leadership Sinai Centre for Diabetes
Lebovic Building
5th Floor, L5-024
Mount Sinai Hospital
600 University Avenue
Toronto, ON
M5G 1X5
Canada
| Phone | +1 416 586 8747 |
|---|---|
| zinman@mshri.on.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Renin Angiotensin SyStem blockade: diabetes nephropathy |
| Study acronym | RASS |
| Study objectives | Inhibition of the renin angiotensin system will protect the kidney. |
| Ethics approval(s) | Approval received from the Mount Sinai research ethics board |
| Health condition(s) or problem(s) studied | Diabetic Nephropathy (DN) |
| Intervention | 1. Angiotensin-Converting Enzyme (ACE) inhibitor: Enalapril 2. Angiotensin Receptor Blocker: Losarten |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Enalapril, Losarten |
| Primary outcome measure(s) |
The primary outcome is to determine, in Type one diabetes without clinical evidence of diabetic nephropathy, if inhibition of the renin-angiotensin system activity can prevent or retard the rate of development of the histologic lesions associated with diabetic nephropathy. |
| Key secondary outcome measure(s) |
1. Retinopathy |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 285 |
| Total final enrolment | 223 |
| Key inclusion criteria | 1. Patients with type one diabetes 2. Normal Glomerular Filtration Rate (GFR) and Blood Pressure (BP) 3. Normoalbuminuria 4. Either sex, 18 to 64 years of age |
| Key exclusion criteria | 1. Type one Diabetes Mellitus longer then 20 years 2. BP more than 135/85 mmHg 3. GFR less than 90 ml/min 4. Microalbuminuria 5. Soiltary kidney 6. Other chronic disease 7. Pregnancy or planning pregnancy within two years of randomisation |
| Date of first enrolment | 01/03/1997 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Leadership Sinai Centre for Diabetes
Toronto, ON
M5G 1X5
Canada
M5G 1X5
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/08/2011 | 27/10/2021 | Yes | No |
Editorial Notes
27/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
