The effect of Sevelamer Hydrochloride and Calcium Carbonate on serum level of hs-CRP, soluble CD-14, and endotoxin in hemodialysis patients will be studied.
Design
Randomized clinical trial on two parallel groups, without blinding, phase 4 on 50 patients, which will use Rand list software for randomization.
Settings and conduct
The present study will be performed on hemodialysis patients referred to Imam Reza Hospital of Tabriz University of Medical Sciences. Patients will be randomly divided into two equal groups and will be intervened for two months. At the end of the study, the levels of endotoxin, sCD-14 and hs-CRP will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria are age over 18 years old, end-stage renal disease, hemodialysis for more than three months and indication for treatment with phosphate binders. Also non-inclusion criteria are impossibility of alternative treatment with Sevelamer Hydrochloride or Calcium Carbonate, history of any substance abuse, history of immunological diseases, any cancer, recent active infection, history of previous kidney transplantation and history of receiving immunosuppressive therapy.
Intervention groups
Patients in group A will receive Sevelamer Hydrochloride 800 mg tablets 3 times daily with meals for 2 months and group B patients will receive Calcium Carbonate1000 mg tablets 3 times daily with meals for 2 months.
Main outcome variables
The primary outcomes of the present study are serum levels of endotoxin; sCD-14 and hs-CRP. Also the secondary outcome of the present study is possible side effects of each drug.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200724048193N1
Registration date:2020-11-15, 1399/08/25
Registration timing:registered_while_recruiting
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Shabnam Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3380 5677
Email address
salehish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of hs-CRP, Soluable CD-14 and Endotoxin in Hemodialysis Patients
Public title
Comparing the Effect of Sevelamer Hydrochloride and Calcium Carbonate on Serum Level of Inflammatory Markers in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ESRD
Indication of treatment with phosphate binders
Hemodialysis preformation for more than three months
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease
Primary outcomes
1
Description
Endotoxin
Timepoint
At the beginning of the study and two months after starting treatment
Method of measurement
Serum level measurement
2
Description
high-sensitivity C-reactive protein
Timepoint
At the beginning of the study and two months after starting treatment
Method of measurement
Serum level measurement
3
Description
Soluable CD-14
Timepoint
At the beginning of the study and two months after starting treatment
Method of measurement
Serum level measurement
Secondary outcomes
1
Description
Possible side effects
Timepoint
Two months after starting treatment
Method of measurement
Assessment and questioning of the patient
Intervention groups
1
Description
Intervention group: Receiving 800 mg Sevelamer Hydrochloride tablets product by Faran Shimi pharmaceutical 3 times a day with meal for 2 months
Category
Treatment - Drugs
2
Description
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