The purpose of this study is to evaluate the effect of Pioglitazone on proteinuria in patients with non diabetic renal disease. Sample size consists of 42 cases. Inclusion criteria: 1. proteinuria (>500 mg/ day) for at least 6 months; 2. controlled blood pressure for at least 6 months; 3. age more than 18 years; 4. BMI less than 30; 5. serum creatinin less than 6 mg/dl; 6. no diabetes; 7. not using immunosuppressor agents; 8. no heart failure; 9. no liver disease. Exclusion criteria: 1. changes in doses of drugs which have effect on proteinuria (for example ACEI); 2. incidense of complications attributable to the drugs. In this self-controlled clinical trial 15 mg of Pioglitazone is given to the patients daily for 4 months and their 24 -hour urine protein is evaluated at first and then every 2 months till 2 months after drug discontinuation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805222340N1
Registration date:2010-07-04, 1389/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-04, 1389/04/13
Registrant information
Name
Bahram Pakzad
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1568 3840
Email address
pakzad@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research, Isfahan University of Medical Sciences
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Pioglitazone on proteinuria in patients with non diabetic renal disease
Public title
Effect of Pioglitazone on proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. proteinuria (>500 mg/ day) for at least 6 months; 2. controlled blood pressure for at least 6 months; 3. age more than 18 years; 4. BMI less than 30; 5. serum creatinin less than 6 mg/dl; 6. no diabetes; 7. not using immunosuppressor agents; 8. no heart failure; 9. no liver disease. Exclusion criteria: 1. changes in doses of drugs which have effect on proteinuria (for example ACEI); 2. incidense of complications attributable to the drugs.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a self controlled clinical trial in a before/after method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , University avenue
City
Isfahan
Postal code
Approval date
2008-10-22, 1387/08/01
Ethics committee reference number
387239
Health conditions studied
1
Description of health condition studied
chronic renal failure
ICD-10 code
N18.0
ICD-10 code description
chronic renal failure
Primary outcomes
1
Description
Reduction of proteinuria
Timepoint
Every 2 months
Method of measurement
collection of 24-hour urine protein
Secondary outcomes
empty
Intervention groups
1
Description
15 mg of Pioglitasone, dailly for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan Medical School
Full name of responsible person
Dr Bahram Pakzad
Position
MD/Internal Resident
Other areas of specialty/work
Street address
No 103, 1st lalezar, 15th alley, Ale Mohammad St.
City
Isfahan
Postal code
8193734956
Phone
+98 31 1568 3840
Fax
Email
pakzad@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Shahidi
Position
Nephrologist
Other areas of specialty/work
Street address
Noor and Ali-Asghar Hospitals
City
Isfahan
Postal code
Phone
+98 31 1222 2255
Fax
+98 31 1222 2255
Email
shahidi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Bahram Pakzad
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
8193734956
Phone
+98 31 1568 3840
Fax
Email
pakzad@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)