Protocol summary

Summary
According to the clinical guidelines on chronic kidney disease with hypertension, combination therapy with multiple renin–angiotensin–aldosterone system (RAAS) blockers has been recommended as standard first-line therapy. To date, dual and triple blockade of the RAAS has been evaluated by several investigators. This study aims comparing three (Enalapril,Losartan,Metoral) and two (ََEnalapril , Losatan) directional inhibitions of RAAS in treatment of diabetic nephropathy. Methods & Materials: 103 diabetic patients without ESRD were recruited in Tabriz Sina Hospital during a one-year period. The patients randomized in two groups: group A received triple blockade of RAAS with ACEI+ARB+ß blocker and group B received dual blockade with ACEI+ARB (and placebo). Basal and post treatment parameters (after six months) including blood pressure, urine albumin, serum BUN, Cr, Na, K and HbA1C and GFR were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901293742N1
Registration date: 2010-05-29, 1389/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Hamid Noshad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1541 5023
Email address
noshadh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-26, 1390/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three (enalapril , lozar , metoral ) and two (enalapril , lozar ) drugs inhibition of Renin-Angiotensin-Aldosterone System (RAAS) in treatment of diabetic nephropathy
Public title
Three and two drugs inhibition of Renin-Angiotensin-Aldosterone System (RAAS) in treatment of diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: proteinuria, impaired renal function in diabetic patients. Exclusion criteria: pregnancy, milking, drug allergy, bilateral renal artery stenosis, ESRD, beta blocker contraindication, patient rejection.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 103
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
5138638779
Approval date
2010-03-15, 1388/12/24
Ethics committee reference number
8819

Health conditions studied

1

Description of health condition studied
diabetic nephropathy
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus

Primary outcomes

1

Description
proteinuria
Timepoint
one month
Method of measurement
urine exam

2

Description
kidney function
Timepoint
one month
Method of measurement
urine and blood exam

Secondary outcomes

1

Description
blood pressure
Timepoint
one month
Method of measurement
blood pressure measurment by sphygmomonometere

2

Description
Blood potassum
Timepoint
one month
Method of measurement
Blood Biochemistery

3

Description
HgA1c
Timepoint
one month
Method of measurement
Blood biochemistery

4

Description
Na
Timepoint
one month
Method of measurement
Blood biochemistery

Intervention groups

1

Description
Case:enalapril 5mg bid,lozar 25mg bid,metoral 50mg bid
Category
Treatment - Drugs

2

Description
contol:enalapril 5 mg bid,lozar 25 mg bid.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr.Hamid Noshad
Street address
Sina hospital
City
Tabriz

2

Recruitment center
Name of recruitment center
Sheikholraeis clinic
Full name of responsible person
Dr.Hamid Noshad
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.Ostad Rahimi
Street address
Tabriz university of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.Hamid Noshad
Position
Nephrologist
Other areas of specialty/work
Street address
Tabri , Sina hospital
City
Tabriz
Postal code
Phone
+98 41 1541 5023
Fax
Email
hamidnoshad1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr.Hamid Noshad
Position
Nephrologist
Other areas of specialty/work
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 1541 5023
Fax
Email
hamidnoshad1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tbriz university of medical sciences
Full name of responsible person
Dr.Hamid Noshad
Position
Nephrologist
Other areas of specialty/work
Street address
Tabriz , Sina hospital
City
Tabriz
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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