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IRCT20201108049311N1 IRCT 2020-12-16 Personal expense The association between intravenous iron and cardiovascular complications in hemodialysis patients The association between intravenous iron and prescribe recombinant erythropoietin and cardiovascular events in hemodialysis patients 2020-09-22 anticipated 60 Complete https://irct.ir/trial/52527 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 chronic kidney disease. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no data.
public Dr. Farahnoosh Farnood
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3336 9331 farnood_farahnoosh@yahoo.com Tabriz University of Medical Sciences scientific Dr. Farahnoosh Farnood
Kidney Research Center, one floor, Imam Reza training and Research Center, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3336 9331 farnood_farahnoosh@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 80 years Both >700 Ferritin level and/or >40% Iron saturation Having an active infection D63.1 Anemia in chronic kidney disease Treatment - Drugs Treatment - Drugs 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. 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. 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. Personal expense Approved 2020-09-15 Ethics committees of Islamic Azad university of Tabriz Tabriz Branch of Islamic Azad University, Pasdaran highway, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)