The effect of pentoxifylline on improving of anemia hyporesponsive to recombinant human erythropoietin among patients with ESRD on chronic hemodialysis; a randomized, double blind clinical trial
In this randomized double-blind, placebo-controlled clinical trial, 60 patients with chronic hemodialysis who had hemoglobin level less than 11 gr/dL despite receiving 100-200 IU/Kg/W recombinant erythropoietin at least 3 months before starting the study were included.
Patients were randomly assigned according to a computer- generated list into the control or case group (30 patients in each group). In the case group patients treated with Pentoxiphyllin 400 mg daily and Patients in the control group took a placebo tablet daily for 4 months.
hemoglobin, ESR, CRP and serum iron profile including ferritin and TIBC (monthly) was recorded in a questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042117380N1
Registration date:2014-05-12, 1393/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Farzane Najafi
Name of organization / entity
Shahid Sadughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4000
Email address
drfnajafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research- Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-05-15, 1393/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pentoxifylline on improving of anemia hyporesponsive to recombinant human erythropoietin among patients with ESRD on chronic hemodialysis; a randomized, double blind clinical trial
Public title
The effect of pentoxifylline on improving of anemia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with chronic hemodialysis who had hemoglobin level less than 11 gr/dL despite receiving 100-200 IU/Kg/W recombinant erythropoietin at least 3 months before starting the study.
Exclusion criteria: age< 18 years old; pregnancy; past history of allergy or intolerance to Pentoxiphyllin; the use of hemodialysis catheter in a recent month; paients with active ulcer disease or dyspepsia; major surgery within 3 months ago; blood transfusion in past month; history of myocardial infarction, stroke and brain hemorrhage in 3 months ago; suboptimal dialysis in recent 2 months ( KT/V < 1.2 ); PTH > 300 pg/mL; Iron deficiency ( ferritin level < 100 µg/L or TIBC < 20% ); any hospitalization in past month ; the previous history of hematological problems such as hemoglobinopathies.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
Street address
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
City
Yazd
Postal code
Approval date
2013-07-21, 1392/04/30
Ethics committee reference number
75377/1/17/پ
Health conditions studied
1
Description of health condition studied
Anemia in patients with hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
mean changes in hemoglobin concentrations
Timepoint
4 times, monthly
Method of measurement
with CBC
Secondary outcomes
1
Description
Erythrocyte Sedimentation Rate
Timepoint
each 2 months
Method of measurement
with lab tests
2
Description
C Reactive Protein
Timepoint
each 2 months
Method of measurement
with lab tests
Intervention groups
1
Description
case group:400 mg of pentoxifylline daily for 4 months
Category
Treatment - Drugs
2
Description
control group: 1 placebo tablet daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Center, Shahid Rahnemon Hospital
Full name of responsible person
Dr Mohsen Gholinataj
Street address
Shahid Sadoughi Hospital, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Hassan Mozaffari
Street address
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
City
Yazd
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 -Shahid Sadoughi University of Medical Science
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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Mohsen Gholinataj
Position
MD, internal medicine resident
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
mghnataj@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Farzane Najafi
Position
Assistant professor, Internal medicine
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfnajafi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Farzane Najafi
Position
Assistant professor, Internal medicine
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfnajafi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)