Determination of the effect of pentoxifylline on microalbuminuria in patients with diabetic nephropathy
Design
Double-blind, randomized clinical trial with one control group
Settings and conduct
A double blind study on the effects of Pentoxifylline on microalbuminuria in diabetic type II patients that will take place in Imam Khomeini, Ahvaz, Khouzestan, Iran. Patients, the care provider and data gatherers are blinded.
Participants/Inclusion and exclusion criteria
Type 2 diabetic Outpatients aged 18-80 referred to the nephrology clinic of Imam Khomeini Hospital;
Inclusion Criteria: Proteinuria more than 150mg/24hours; Microalbuminuria of more than 20 mg albumin excretion in 24 hour urine
Exclusion Criteria: Patients Suffering from Diabetic Retinopathy; Hypersensitivity to pentoxifylline; Pregnancy; Heart failure with Ejection fraction less than 35%; Any acute or febrile illness one month before induction to study; Use of spironolactone; Use of Warfarin
Intervention groups
After being divided into two groups and baseline lab tests, patients are treated with medication for 12 weeks, depending on the group.
Intervention group: In addition to medications for the underlying disease, patients in this group use pentoxifylline 400 mg (Farabi Co., Iran) once a day, after meals.
Control group: In addition to the drugs used for the underlying disease, patients in this group use a placebo designed in Jundishapur School of Pharmacy, which is similar in appearance to Pentoxifylline 400 mg, once a day and after meal.
Main outcome variables
Albuminuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042264N3
Registration date:2020-12-16, 1399/09/26
Registration timing:registered_while_recruiting
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Ehsan Hedayatinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 3368
Email address
hedayatee.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-19, 1400/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of pentoxifylline on microalbuminuria in type 2 diabetic patients
Public title
The effect of pentoxifylline on diabetic microalbuminuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type II Diabetic Patients
Proteinuria more than 150mg/24hours
Microalbuminuria of more than 20 mg albumin excretion in 24 hour urine
Exclusion criteria:
Patients Suffering from Diabetic Retinopathy
Hypersensitivity to pentoxifylline
Pregnancy
Heart failure with Ejection fraction less than 35%
Any acute or febrile illness one month before induction to study
Use of spironolactone
Use of Warfarin
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Using a Sequence Generator (freely available at www.random.org), A set of numbers from 1 to 58 was requested in two columns, the results were two columns of 29 Integers from one to 58, without repetition, which were used for division.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining a series of unsorted random numbers from the website, this series of numbers is provided to the pharmacist by the statistical consultant to code the drugs. The pharmacist then sorts the drug and placebo in encoded packages. After the eligible patients are referred, the drugs are given to them in the order of referral. Patients, prescribing physicians, and data collectors are kept blind to the contents of the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.075
Health conditions studied
1
Description of health condition studied
Albuminuria in patients with diabetes Mellitus type II
ICD-10 code
E08.2
ICD-10 code description
Diabetes mellitus due to underlying condition with kidney complications
Primary outcomes
1
Description
Albuminuria
Timepoint
before intervention, 12 weeks after intervention
Method of measurement
24-hour urine collection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with pentoxifylline 400 mg (Farabi Company; Iran) once a day, after meals. This treatment lasts for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with placebo (produced in the Faculty of Pharmacy of Ahvaz Jundishapur University) once a day, after meals. This treatment lasts for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital
Full name of responsible person
Shokouh Shayanpour
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
shayanpour-sh@ajums.ac.ir
Web page address
https://himam.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Central library, Ahvaz Jundishapur University of Medical Sciences, Esfand St, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
CRD-9908
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
shayanpour-sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
shayanpour-sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
shayanpour-sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available