The purpose of this study was to evaluate the effect of pentoxyphylin on hemoglobin level and erythropoietin dose changing in hemodialysis patients with anemia. This study was done in hemodialysis centers in Isfahan (Zahraye Marziye) and Khomeini Shahr (Saei). The patients who were on hemodialysis for at least one month prior to the study, were assigned to receive pentoxyphylin tablet, 400mg daily for 6 months or placebo. Hemoglobin, Iron, Ferritin and serum iron binding capacity were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011102417N4
Registration date:2010-12-30, 1389/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-30, 1389/10/09
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
2010-04-04, 1389/01/15
Expected recruitment end date
2010-09-06, 1389/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxyphilin for reduce of erythropoietin needs in hemodialysis patiente with anemia
Public title
Effect of pentoxyphilin for reduce of erythropoietin needs in hemodialysis patiente with anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient’s satisfaction, hemodialysis for at least 1 month, hemoglobin concentration <10g/dL in at least 2 episode, Erythropoietin use ≥12000unit per week, no bleeding over past month, no infection resulting admission in past month, vitamin C use, 2 tablet 250mg per week
Exclusion criteria: drug intolerance, bleeding during the study, infection resulting admission
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Isfahan 1000 jarib
City
Isfahan
Postal code
Approval date
2010-02-20, 1388/12/01
Ethics committee reference number
287029
Health conditions studied
1
Description of health condition studied
Ens stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
serum hemoglobin level
Timepoint
onset, monthly,end of study
Method of measurement
g/dL
2
Description
serum albumin
Timepoint
onset, monthly, end of study
Method of measurement
g/dL
3
Description
Erythropoietin use
Timepoint
monthly
Method of measurement
International unit
Secondary outcomes
1
Description
Total iron binding capacity
Timepoint
Baseline, 3rd month, at the end of study
Method of measurement
µg/dL
2
Description
serum Iron level
Timepoint
Baseline, 3rd month, at the end of study
Method of measurement
µg/dL
Intervention groups
1
Description
Pentoxyphylin, 400mg orally daily for 6 months
Category
Treatment - Drugs
2
Description
Placebo daily for 6 months orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahraye Marziye Dialysis Center
Full name of responsible person
Rezvan Nasiri
Street address
Zeinabiye Street Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Saei Dialysis Center
Full name of responsible person
Rezvan Nasiri
Street address
Isfahan, Khomeini Shahr, Saei Hospital
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
Vice Chancellor for Research
Street address
Hezarjarib, Isfahan
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 Science
Full name of responsible person
Dr. Mojgan Mortazavi
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1260 2593
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Associate Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1260 2593
Fax
Email
m_mortazavi@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 Firouzeh Moeinzadeh
Position
Assistant Professor of Internal Medicine
Other areas of specialty/work
Street address
Azahra Hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)