Effect of Pentoxifylline on inflammatory factors and quality of life in hemodialysis patients
Design
Randomized , Double blind , Clinical trial with control group , with parallel groups ,with 100 hemodialysis patients, based on previous studies.
Settings and conduct
Patients with chronic renal failure undergoing hemodialysis in the hemodialysis department of Emam Reza Hospital;None of the treatment staff and patients were aware of which patients received medocation or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:CRP>1;Age over 18 years; Initiate hemodialysis for at least 3 months and three times a week ;Ability to understand and sign a consent form; Properly functioning arteriovenous fistula or catheter ;Dialysis adequacy above 1.2
Exclusion criteria:Pregnancy ;The presence of any chronic,active,uncontrolled or severe chronic inflammatory disease(autoimmune disease,connective tissue disease,malignancy,HIV,liver disaese and pulmonary disease) ;The presence of chronic infection or the occurrence of acute infection in a recent month; Hemoglobin is less than 10g/dL ;Concurrently presence in another trial(drug or supplement) ;A medical history(such as heart attack or brain injury)or sergical in the last 3 months ;Symptoms of malabsorption; Bleeding disorders(Includes coagulopathies)or high risk of bleeding; Change in diet in the last 1 month ;Abuse of alcohol and other substances that cause dependence
Intervention groups
Intervention group: The treatment group consists of 50 patients receiving 400 mg orally of Pentoxifylline daily for 3 months
Main outcome variables
serum level of TNF-α
serum level of CRP
Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N3
Registration date:2019-09-21, 1398/06/30
Registration timing:registered_while_recruiting
Last update:2019-09-21, 1398/06/30
Update count:0
Registration date
2019-09-21, 1398/06/30
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifylline on inflammatory factors and quality of life in hemodialysis patients
Public title
Effect of pentoxifylline on inflammatory factors and quality of life in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
CRP>1
Age over 18 years
Initiate hemodialysis for at least 3 months and three times a week
Ability to understand and sign a consent form
Properly functioning arteriovenous fistula or catheter
Dialysis adequacy above 1.2
Exclusion criteria:
Pregnancy
The presence of any chronic,active,uncontrolled or severe chronic inflammatory disease(autoimmune disease,connective tissue disease,malignancy,HIV,liver disaese and pulmonary disease)
The presence of chronic infection or the occurrence of acute infection in a recent month
Hemoglobin is less than 10g/dL
Concurrently presence in another trial(drug or supplement)
A medical history(such as heart attack or brain injury)or sergical in the last 3 months
Symptoms of malabsorption
Bleeding disorders(Includes coagulopathies)or high risk of bleeding
Change in diet in the last 1 month
Abuse of alcohol and other substances that cause dependence
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Permuted Block Randomization method was used for entering patients in control and treatment groups. In this method, each block contained an equal number of treatment groups and control group. Random numbers in this study were given using the Excel program to determine random blocks and random groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is conducted in a single blind clinical trial. None of the people distributing drugs and patients are aware of which patients receive the drug or placebo, and are only diagnosed with the numbers given by the system to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 central building , Tabriz University of Medical sciences , Golgasht Street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.TBZMED.REC.1397.954
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
serum level of TNF-α
Timepoint
Before intervention. At the end of the intervention
Method of measurement
ELISA kit
2
Description
serum level of CRP
Timepoint
Before intervention. At the end of the intervention
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention. At the end of the intervention
Method of measurement
Standard questionnaire
Intervention groups
1
Description
Intervention group: The treatment group consists of 50 patients receiving 400 mg orally of Pentoxifylline daily for 3 months
Category
Treatment - Drugs
2
Description
Control group consisted of 50 patients receiving 400 mg orally of placebo(which apart from the active ingredient,were similar to Pentoxifylline tablets )daily for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Email
gharekhania@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr abolghasem Jouyban
Street address
Center of Tabriz Medical University,Daneshgah St, Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3335 7310
Fax
+98 41 3336 3231
Email
ajouyban@hotmail.com
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
gharekhania@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Lachin Rezadoust
Position
Pharmacy Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
lachinrzdst@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Demographic data and main outcomes will be shared
When the data will become available and for how long
Data files will become available 6 months after publication
To whom data/document is available
It will be only available for people working in academic institutions
Under which criteria data/document could be used
All of the data can be freely used if the citation is appropriately considered
From where data/document is obtainable
The applicants will be referred to research Vice-chancellor
What processes are involved for a request to access data/document
All of the requsted data should be mentioned in a application letter which will be sent to the Research Vice-chancellor of Tabriz University of Medical Sciences.