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IRCT20200724048193N1 IRCT 2020-11-15 Tabriz University of Medical Sciences Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of Inflammatory Markers in Hemodialysis Patients Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients 2020-10-22 anticipated 40 Complete https://irct.ir/trial/51370 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using Rand list software version 1.2 based on patients' file numbers and creating a random number table. Patients will be randomly divided into two equal groups and randomly assigned to the Sevelamer Hydrochloride or Calcium Carbonate group. 4 End Stage Renal Disease. Intervention 1: Intervention group: Receiving 800 mg Sevelamer Hydrochloride tablets product by Faran Shimi pharmaceutical 3 times a day with meal for 2 months. Intervention 2: Intervention group: Receiving 500 mg Calcium Carbonate tablets product by Jalinous pharmaceutical at dose of 1000 mg 3 times a day with meal for 2 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Shabnam Salehi
Emam Reza Hospital, Daneshgah Street, Daneshgah Square
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3966 salehish@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Shabnam Salehi
Emam Reza Hospital, Daneshgah Straat, Daneshgah Square
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3966 salehish@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with ESRD Indication of treatment with phosphate binders Hemodialysis preformation for more than three months 18 years no limit Both Impossibility of alternative treatment with Sevelamer Hydrochloride or Calcium Carbonate Cigarette, alcohol and drug abuse History of immunological diseases Any type of cancer Recent active infection Previous kidney transplant history History of receiving immunosuppressive treatment I13.11 Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease Treatment - Drugs Treatment - Drugs Intervention group: Receiving 800 mg Sevelamer Hydrochloride tablets product by Faran Shimi pharmaceutical 3 times a day with meal for 2 months Intervention group: Receiving 500 mg Calcium Carbonate tablets product by Jalinous pharmaceutical at dose of 1000 mg 3 times a day with meal for 2 months Endotoxin. Timepoint: At the beginning of the study and two months after starting treatment. Method of measurement: Serum level measurement. High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and two months after starting treatment. Method of measurement: Serum level measurement. Soluable CD-14. Timepoint: At the beginning of the study and two months after starting treatment. Method of measurement: Serum level measurement. Possible side effects. Timepoint: Two months after starting treatment. Method of measurement: Assessment and questioning of the patient. Tabriz University of Medical Sciences Approved 2015-08-24 Ethics Committee of Tabriz University of Medical Sciences 6th floor, No.116, 7th Sahand Alley, Sahand Blvd, Tabriz, Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)