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Effect of pentoxifyllin on microalbominuria in patients with diabetic nephropathy

Protocol summary

Summary
Pentoxyphilin is a phosphodiesterase inhibitor that can decrease proteinuria in patients. The purpose of this study is evaluation of effect of pentoxyphylin on micoalbuminuria in diabetic patients. We selecte 40 diabetic patients that their estimated glomerular filtration rate is higher than 60 mL/min, spot urine albumin-creatinine ratio lesser than 300 mg/g, blood pressure less than 140/90 mmHg by using anti-hypertensive drugs and glycosylated hemoglobin less than 8%. If they have myocardial infarction, stroke, retinal hemorrhage in previous 6 months, immunosupresion drug useage, nonsteroidal anti-inflammatory drugs useage or changing in antihypertensive drugs, are excluded from study. The patients are categorized in two groups and receive pentoxyphylin tablet, 400mg, manufactured by Amin Pharmaceutical, IRAN, 3 times a day for 6 months ,or placebo group as the same . Serum creatinine and spot urine albumin-creatinine ratio are measured at the beginning, three and six months later and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312212417N15
Registration date: 2014-02-23, 1392/12/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifyllin on microalbominuria in patients with diabetic nephropathy
Public title
Effect of pentoxifyllin on microalbominuria in patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Estimated glomerular filtration rate: higher than 60 mL/min/1.73 m2; 2.Blood pressure: less than 140/90 mmHg by using anti hypertensive drugs in the last six month 3.protein intake: less than 0.8gr/kg/d; 4.controlled blood glucose (glycosylated hemoglobin: less than 8%); 5.Spot urine albumin to creatinine ratio: less than 300 mg/g in 3 consecutive measurements during a 3 months screening period. exclusion criteria: 1.Myocardial infarction; 2.Stroke; 3.Retinal hemorrhage in last 6 months; 4.abnormal liver function tests ; 5.Congestive heart failure (New York Heart Association class III or IV); 6.Obstructive uropathy 7.Active malignancy; 8.Patients who could not discontinue immunosuppressive or nonsteroidal anti inflammatory drugs; 9.Pregnant or breast feeding women 10. changes in anti-hypertensive drugs 11.other cause of proteinuria
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
isfahan
Postal code
Approval date
2011-09-29, 1390/07/07
Ethics committee reference number
290183

Health conditions studied

1

Description of health condition studied
Diabetic nephropathy
ICD-10 code
NO8.3
ICD-10 code description
Diabetic nephropathy

Primary outcomes

1

Description
Albumin/creatinine ratio of random urine sample
Timepoint
At begining, three and six months later
Method of measurement
Photometric method (mg/g)

2

Description
Glomerular filtration rate
Timepoint
At begining and the end of study
Method of measurement
Modification of Diet in Renal Disease (MDRD formula)

Secondary outcomes

empty

Intervention groups

1

Description
Placebo tablet: three times a day for 6 months manufactured by amin company
Category
Placebo

2

Description
Pentoxifyllin tablet: 400 mg three times a day for 6 month manufactured by amin company
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan endocrine and metabolism research center
Full name of responsible person
Dr marzieh hoseinbalam
Street address
khorram street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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 University of Medical Sciences
Full name of responsible person
Dr.marzieh hoseinbalam
Position
Internal medicine resident
Other areas of specialty/work
Street address
Sofe street, Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
drhoseinbalam@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.shahrzad shahidi
Position
Proff of Nephrology
Other areas of specialty/work
Street address
Sofe street, Alzahra hospital
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
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. marziyeh hoseinbalam
Position
Internal medicine resident
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 1669 4426
Fax
Email
drhoseinbalam@yahoo.com
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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