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Evaluation of the effect of pentoxifylline 400 mg on anemia control and decreasing the dose of erythropoietin in chronic hemodialysis patients

Protocol summary

Study aim
Determine the effect of pentoxifylline 400 mg on anemia control and decreasing the dose of erythropoietin in chronic hemodialysis patients
Design
Phase 3 controlled clinical trial, randomized by random blocks, with parallel groups, on 16 samples
Settings and conduct
Before the intervention, an initial assessment will be made. Then, the patients will be randomly assigned to two treatment and control groups by random block method.The intervention group will receive the 400 mg pentoxifylline pill once daily for 12 weeks. The control group, apart from the standard treatment that both groups receive (intravenous erythropoietin), will not have any additional intervention.The CRP test will be performed at the time of admission and after taking the medication. Also, hemoglobin level fluctuations of patients during the study will be followed up on monthly trials of patients and at the beginning and end of the study and if it increases to more than 11, the dose of erythropoietin will be reduced by 30% and, if continued less than 11, the doses of erythropoietin will increase by 30%. During the study, the side effects of the drug in patients including abdominal discomfort, gastrointestinal bleeding, gum bleeding and conjunctival hemorrhage will be evaluated and if they happen, patients will be excluded from the study. All steps of the research from intervention to clinical and paraclinical examinations will be done in Shahid Beheshti Hospital in Anzali.
Participants/Inclusion and exclusion criteria
Hemodialysis patients referring to Hemodialysis Center of Anzali Shahid Beheshti Hospital with anemia; GFR less than 15; hemodialysis in the last 3 months, as well as no history of hemorrhages and infections leading to hospitalization in a recent month are included in the study.
Intervention groups
Group 1: Intervention with 400 mg pentoxifylline pill, made in Iran, once daily for 12 weeks and Group 2: control group (no medication). Both groups will receive an appropriate dosage of intravenous erythropoietin diagnosed by physician
Main outcome variables
Anemia control; reducing the need for intravenous erythropoietin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180122038471N1
Registration date: 2018-02-08, 1396/11/19
Registration timing: registered_while_recruiting

Last update: 2018-02-08, 1396/11/19
Update count: 0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Pegah Aghajanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
paghajanzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pentoxifylline 400 mg on anemia control and decreasing the dose of erythropoietin in chronic hemodialysis patients
Public title
The effect of pentoxifylline 400 mg on anemia control and decreasing the dose of erythropoietin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GFR less than 15 Have been under hemodialysis for at least 3 months Performing regular hemodialysis 3 times a week Having an iron saturation of more than 30% and ferritin more than 500 Dialysis adequacy criteria: Kt/V greater than 1/2 Have an arteriovenous fistula or a pacifier for hemodialysis Hemoglobin less than 11 in at least 2 consecutive tests within a month
Exclusion criteria:
History of bleeding in a recent month History of infection leading to hospitalization in a recent month Use of theophylline and androgens Intolerance to drug use in oral form Patient dissatisfaction The patient has undergone blood transfusion or B12 administration for any reason during the last 3 months. The presence of any underlying illness that justifies anemia, including thyroid and parathyroid dysfunction, hemoglobinopathy and malnutrition, and ... Hemorrhagic retinopathy The presence of coronary artery disease in the last 3 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random block method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite the 17th Shahrivar Hospital, Ciadati Ave, Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2017-12-30, 1396/10/09
Ethics committee reference number
IR.GUMS.REC.1396.419

Health conditions studied

1

Description of health condition studied
Anemia
ICD-10 code
D46.4
ICD-10 code description
Refractory anemia, unspecified

Primary outcomes

1

Description
Hemoglobin level
Timepoint
At the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 400 mg pentoxifylline pill, made in Iran, once daily for 12 weeks, with an appropriate dosage of intravenous erythropoietin for each patient diagnosed by physician
Category
Treatment - Drugs

2

Description
Control group: Routine care and no additional intervention with an appropriate dosage of intravenous erythropoietin for each patient diagnosed by physician
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis Center of Shahid Beheshti Hospital, Anzali
Full name of responsible person
Pegah Aghajanzadeh
Street address
Shahid Beheshti Hospital, Kalivar 2 St., Anzali
City
Rasht
Province
Guilan
Postal code
43198-93151
Phone
+98 13 4450 2004
Fax
+98 13 4450 5212
Email
drpegah_a@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Dr. Siavsh Falahatkar
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
falahatkar_s@yahoo.com
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan 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
Rasht University of Medical Sciences
Full name of responsible person
Samira Rahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc1384@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Pegah Aghajanzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
drpegah_a@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Non-faculty researcher
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@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
All patient information is confidential and their publication is not ethically correct. Information will only be published in the form of report or/and scientific paper.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
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
Yes - There is a plan to make this available
Title and more details about the data/document
All information, study protocol, results, forms and ... will be published in the form of scientific paper.
When the data will become available and for how long
One month after the publication of the article, it will start to be available.
To whom data/document is available
All researchers in Iran who are affiliated with one of the academic or research institutes approved by the Ministry of Health and Medical Education.
Under which criteria data/document could be used
In case of doing Cohort studies or multicentre studies by other eligible researchers
From where data/document is obtainable
Dr. Pegah Aghajanzadeh, executor of project and Dr. Siavash Falahtakar, Head of Urology Research Center Address: Urology Research Center, Razi Hospital, Rasht Phone: 013- 33525259
What processes are involved for a request to access data/document
Submitting a written request for the head of the Urology Research Center, stating the request to the project executive other colleagues and getting their approval, writing a written opinion to the applicant, taking the moral obligation of the applicant, sending the data and documentation to the applicant
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