The association between intravenous iron and prescribe recombinant erythropoietin and cardiovascular events in hemodialysis patients
Design
60 patients with chronic kidney disease in hemodialysis will included in the study via simple random non-probability Sampling method consecutively. After that patients will randomly be divided into two similar groups (low Iron regimen group and high Iron regimen group) with random digits table. All data will remain private with encoding method.
Settings and conduct
Patient recruitment will be perform in Sina and 29 Bahman hospitals between 98-99 years. Thus, patients' data will be collected before study beginning and Ferritin level and Iron saturation rate, incidence of acute myocardial ischemia, cerebral stroke, heart failure, mortality rate, and the required monthly prescribed dose of erythropoietin will be monthly measured in both two groups of intravenous Iron receiving during 6 months clinical trial.
Participants/Inclusion and exclusion criteria
1- Be volunteer to participate in the study
2- Patients with end-stage renal disease that have undergone six months of their dialysis
3- Age group of 18-80 years
Intervention groups
Intervention group: high regimen of Iron: Including patients with <700 ferritin and/or <40% Iron saturation that will receive monthly 400 mg intravenous Iron for 6 months. Control group: low regimen of Iron: Including patients with <200 ferritin and/or <20% Iron saturation that will receive weekly 100 mg intravenous Iron for 6 months.
Main outcome variables
Decreasing the required weakly dose of Erythropoietin, Reducing cardiovascular events
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201108049311N1
Registration date:2020-12-16, 1399/09/26
Registration timing:registered_while_recruiting
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Seyyedeh Mina Hejazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 9331
Email address
smhjz.biotech@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The association between intravenous iron and prescribe recombinant erythropoietin and cardiovascular events in hemodialysis patients
Public title
The association between intravenous iron and cardiovascular complications in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be volunteer to participate in the study
Patients with end-stage renal disease that have undergone six months of their dialysis
Age group of 18-80 years
Exclusion criteria:
>700 Ferritin level and/or >40% Iron saturation
Having an active infection
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be by blocking method and groups division will be perform with an equal number of patients individually. Patients will divided by random digit table. Thus, the statistical population and sample size will be determined first and they will be respectively given a code or serial number. Then, the entered codes will be selected randomly from the table. All participants in this study were blinded unilaterally. Randomly allocation concealment will also go on with the method of not determining study groups before selecting patients and included individuals will be randomly grouped after sampling in this study.
Blinding (investigator's opinion)
Single blinded
Blinding description
All names and personal data of patients will encode during gathering data and will remain totally private. In addition, none of the participants will be grouped at the beginning of study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Islamic Azad university of Tabriz
Street address
Tabriz Branch of Islamic Azad University, Pasdaran highway, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.IAU.TABRIZ.REC.1399.083
Health conditions studied
1
Description of health condition studied
chronic kidney disease
ICD-10 code
D63.1
ICD-10 code description
Anemia in chronic kidney disease
Primary outcomes
1
Description
Decreasing the required weakly dose of Erythropoietin
Timepoint
Monthly during 6 month prescription of intravenous Iron
Method of measurement
Performing blood test and ELISA method
2
Description
Reducing cardiovascular events
Timepoint
Monthly during 6 month prescription of intravenous Iron
Method of measurement
Investigating the incidence of chronic myocardial ischemia, cerebral stroke, heart failure and mortality rate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High regimen of Iron: Including patients with <700 ferritin and/or <40% Iron saturation that will receive monthly 400 mg intravenous Iron for 6 months.
Category
Treatment - Drugs
2
Description
Control group: Low regimen of Iron: Including patients with <200 ferritin and/or <20% Iron saturation that will receive weekly 100 mg intravenous Iron for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr. Farahnoosh Farnood
Street address
Sina training and Research Center, Azadi Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
farnood_farahnoosh@yahoo.com
2
Recruitment center
Name of recruitment center
29 Bahman hospital
Full name of responsible person
Dr. Farahnoosh Farnood
Street address
29 Bahman hospital, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166617894
Phone
+98 41 3330 7000
Email
farnood_farahnoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Personal expense
Full name of responsible person
Dr. Farahnoosh Farnood
Street address
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 9331
Email
farnood_farahnoosh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal expense
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farahnoosh Farnood
Position
Subspecialty physician
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 9331
Email
farnood_farahnoosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farahnoosh Farnood
Position
Subspecialty physician
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 9331
Email
farnood_farahnoosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farahnoosh Farnood
Position
Subspecialty physician
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Kidney research center, 1 floor, Imam Reza medical research & training hospital, Golghasht Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۵۶
Phone
+98 41 3336 9331
Email
farnood_farahnoosh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available