The objective of this study was to assess the effect of Simvastatin on the inflammatory factors and GFR of patients with chronic renal failure. 40 patients with chronic renal failure aged between 15 and 70, GFR between 20 and 70 and LDL more than were divided to two groups. Intervention group received Simvastatin 20 mg daily and control groups didn’t receive any treatment. Lipid profile (cholesterol, triglyceride, LDL, and HDL), inflammatory markers (IL-6, CRP, and HS) and renal function (GFR, BUN, and creatinin) were measured and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712071698N3
Registration date:2009-10-26, 1388/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-10-26, 1388/08/04
Registrant information
Name
Mahmood Akhzari
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 0191
Email address
akhzari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2008-12-21, 1387/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Simvastatin on inflammatory marker and improvement of GFR in CRF patient
Public title
Effect of Simvastatin on inflammatory marker and improvement of GFR in CRF patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15-70 years, presence of chronic renal failure, LDL more than 100
Exclusion criteria: Immune deficiency, receiving corticosteroid, NSAID or other drugs that affect on lipid profile, LDL>100, presence of malignancy or connective tissue disorder, hypersensitivity to Simvastatin
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2008-09-15, 1387/06/25
Ethics committee reference number
CT-78-4183
Health conditions studied
1
Description of health condition studied
Chronic Renal Failure
ICD-10 code
N18.0
ICD-10 code description
Diseases of the genitourinary system
Primary outcomes
1
Description
Renal Function Test
Timepoint
Baseline and 4 months after intervention
Method of measurement
GFR, BUN, Creatinine
Secondary outcomes
1
Description
IL6
Timepoint
Baseline and 4 months after intervention
Method of measurement
Direct Serum Measurement (ELISA)
2
Description
Lipid profile (TG, CHOLESETROL, HDL, LDL)
Timepoint
Baseline and 4 months after intervention
Method of measurement
Direct measurement of TG, Cholestrol, and HDL, and LDL by formula
3
Description
HS-CRP
Timepoint
Baseline and 4 months after intervention
Method of measurement
Direct Serum Measurement (ELISA)
Intervention groups
1
Description
Simvastatin, 20 mg daily, for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee hospital, Nephrology clinic
Full name of responsible person
Dr. Mahmood Akhzari
Street address
Nemazee Hospital, Internal Medicine Office
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Dabbaghmanesh
Street address
Shiraz University of Medical Sciences, Vice-chancellor for Research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahmood Akhzari
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Nemazee Hospital, Internal Medicine Office
City
Shiraz
Postal code
Phone
+98 711647433262
Fax
Email
akzari@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Mahmood Akhzari
Position
Internist (resident)
Other areas of specialty/work
Street address
Nemazee Hospital, Internal Medicine 0ffice
City
Shiraz
Postal code
Phone
+98 711647433262
Fax
Email
akhzari@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahmood Akhzari
Position
internist (resident)
Other areas of specialty/work
Street address
Namazi Hospital.internal medicine office
City
shiraz
Postal code
Phone
0987116474332-62 internal medicine office:5600
Fax
Email
akhzari@sums..ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)