We aimed to evaluate the Pentoxifylline (PTX) effect on anemia and prescription erythropoietin (EPO) dose in hemodialysis (HD) patients.
Design
60 patients included into a randomized double blind parallel control trial study. We will randomize them into same size groups 30 cases of trial or PTX and control that recive placebo at the same time.
Settings and conduct
Participants will be recruited from among HD patients with anemia in HD center in Shiraz University of Medical Sciences, Shiraz, Iran. Each patient will be given an order number and received the medications in the corresponding prepacked bottles. Clinical investigators and patients will all masked to the treatment assignment.
Participants/Inclusion and exclusion criteria
Participants will be recruited from among HD patients with anemia in HD center in Shiraz University of Medical Sciences, Shiraz, Iran.
Inclusion criteria : age of 18 years and more, receiving 4-hour HD treatments 3 times per week at least for 3 months, hemoglobin (Hb)<11 in at least 2 consecutive tests in a month, and no change in EPO dose for at least 1 month before starting the study. Exclusion criteria include blood transfusion due to any reason in recent 3 months.
Intervention groups
Each patient in the trial group will be received PTX (400mg twice a day for 12 weeks), and control group will be received starch tablet (placebo) for the same 12 weeks.
Main outcome variables
Hemoglobin, erythrocyte sedimentation rate, C-reactive protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100413003698N2
Registration date:2018-07-09, 1397/04/18
Registration timing:retrospective
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Maryam Pakfetrat
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 176360453
Email address
pakfetratm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution the role of pentoxifylline in erythropoietin-resistant anemia in hemodialysis patients
Public title
The role of pentoxifylline in erythropoietin-resistant anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having the age of 18 years and more
receiving HD treatments at least for 3 months
receiving 4-hour HD treatments 3 times per week a
hemoglobin (Hb)<11 in at least 2 consecutive tests in a month
no change in EPO dose for at least 1 month before starting the study.
Exclusion criteria:
blood transfusion due to any reason in recent 3 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We will collecte 60 patients and randomized into same size groups of trial and control as blocking randomization used for allocation sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind
Each patient was given an order number and received the medications in the corresponding prepacked bottles. Patients and who will evaluate the outcome, do not aware of type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Shiraz University of Medical Sciences
Street address
floor7-Vice-Chancellery of Research -Shiraz University of Medical Sciences-Zand street-
City
Shiraz
Province
Fars
Postal code
7193635899
Approval date
2017-04-04, 1396/01/15
Ethics committee reference number
IR.SUMS.REC.1393. 747064
Health conditions studied
1
Description of health condition studied
Kidney dialysis
ICD-10 code
Y84.1
ICD-10 code description
Y84 Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
hemoglobin
Timepoint
at the beginning and the end of the study.
Method of measurement
blood samples will be drawn to measure of hemoglobin
Secondary outcomes
1
Description
erythrocyte sedimentation rate
Timepoint
at the beginning and the end of the study
Method of measurement
blood samples will be drawn
2
Description
C-reactive protein
Timepoint
at the beginning and the end of the study
Method of measurement
blood samples will be drawn
Intervention groups
1
Description
Intervention group: pentoxifylline. Each patient in the trial group will receive received PTX (400mg twice a day for 12 weeks)
Category
Treatment - Drugs
2
Description
Control group: control group will receive starch tablet twice a day for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi Hospital
Full name of responsible person
Maryam Pakfetrat
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1563
Email
pakfetratm@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Bahador
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3233 2366
Email
bahadora@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?