The purpose of this study was evaluation of effect of pentoxy phylin 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). Patients who were on hemodialysis for at least one month and without infection or bleeding in the last month were assigned in one of the following groups after full satisfaction of participation in research. The patients received pentoxyphylin tablet, 400mg or placebo. Blood levels of Hemoglobin, Iron, Ferritin, serum iron binding capacity, and need to erythropoietin were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101012417N6
Registration date:2011-01-13, 1389/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-13, 1389/10/23
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
2009-04-04, 1388/01/15
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 on reducing erythropoietin needs in peritoneal dialysis patiente with anemia
Public title
Effect of pentoxyphilin on reducing erythropoietin needs in peritoneal dialysis patiente with anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient’s satisfaction, hemodialysis for at least 1 month prior to the study, hemoglobin concentration less than 10g/dL in at least 2 episodes, Erythropoietin use more than 12000 units per week, no bleeding over the last month prior to the intervention, no infection resulting admission over the last month prior to the intervention, vitamin C consumption 250mg twice a week
Exclusion criteria: drug intolerance, bleeding during the study period, 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
287028
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
serum hemoglobin level
Timepoint
Baseline, monthly, at the end of the study
Method of measurement
g/dL
2
Description
serum albumin
Timepoint
Baseline, monthly, at the end of the study
Method of measurement
g/dL
3
Description
Erythropoietin use
Timepoint
monthly
Method of measurement
International unit
Secondary outcomes
1
Description
serum Iron level
Timepoint
Baseline, 3rd month, at the end of study
Method of measurement
µg/dL
2
Description
Total iron binding capacity
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
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Peritoneal dialysis center. Alzahra hospital
Full name of responsible person
Mrs. Karimi
Street address
Alzahra hospital, Sofe Ave, Isfahan
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 of Nephrology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1668 5555
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 of Nephrology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1668 5555
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)