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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
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.
