Renin Angiotensin SyStem blockade: diabetes nephropathy

ISRCTN	ISRCTN65752530
DOI	https://doi.org/10.1186/ISRCTN65752530
ClinicalTrials.gov number	NCT00143949
Secondary identifying numbers	DCT-14281

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Bernard Zinman
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
Email	zinman@mshri.on.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Enalapril, Losarten
Primary outcome measure	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.
Secondary outcome measures	1. Retinopathy 2. Microalbuminuria 3. Blood pressure 4. GFR 5. Creatinine
Overall study start date	01/03/1997
Completion date	01/03/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Leadership Sinai Centre for Diabetes

Toronto, ON
M5G 1X5
Canada

Canadian Institutes of Health Research (CIHR) (Canada)
Research organisation

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa, ON
K1A OW9
Canada

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT-14281)

No information available

Merck Frosst Canada & Co (Canada)

No information available

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	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2011	27/10/2021	Yes	No

27/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.