Comparing the effect of sevelamer carbonate and sevelamer hydrochloride on blood level of phosphate, Ca, ph, bicarbonate and gastrointestinal complications in patients undergoing maintenance hemodialysis
Comparison of Sevelamer Carbonate and Sevelamer Hydrochloride Effects on the Level of Calcium, Phosphorus, PH, Bicarbonate and Gastrointestinal Complications in Patients Undergoing Maintenance Hemodialysis
Design
Twenty-two samples are included in each group based on the sample size calculated from the results of a pilot study (with a power of 80% and a type 1 error of 5%). Patients will be selected among those in Valiasr Hospital who are under hemodialysis and have entry conditions. Patients will be divided into two groups of intervention with Sevelamer Hydrochloride and Sevelamer carbonate by block randomization method and each participant will be assigned a code to hide the intervention group.
Settings and conduct
In this randomized clinical trial study, patients who undergoing Hemodialysis in Vali Asr Hospital, Zanjan, Iran will participate in the study. Data analyzer and patients will be blinded. blinding were carried out by codding same shape bottles for both drugs.
Participants/Inclusion and exclusion criteria
Patients who undergo three sessions each week for a period of four hours hemodialysis and have a blood phosphorus level greater than 5.5 mg / dL.
Exclusion criteria: Patients who have not taken limited Phosphorus diet.
Patients who lose their ability to do so during the study
Patients who are absent from dialysis session
Patients who break their access for some reason
Patients who have taken the medication inappropriately
Patients with a history of primary hyperparathyroidism or history of parathyroidectomy.
Patients with a history of gastrointestinal diseases include peptic ulcer, reflux, and constipation
Patients with a history of congestive heart failure (due to electrolyte imbalance)
Patients with chronic obstructive pulmonary disease (COPD) (due to acid and basis disorders).
Intervention groups
group 1: 800 mg Sevelamer Carbonate triple time daily with each meal for 1 month.
group 2: 800 mg Sevelamer Hydrochloride triple time daily with each meal for 1 month.
Main outcome variables
Blood PH ; Calcium level of serum ; serum phosphorus level ; bicarbonate level of serum ; gastrointestinal complications of each drugs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141016019554N13
Registration date:2018-02-17, 1396/11/28
Registration timing:retrospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparing the effect of sevelamer carbonate and sevelamer hydrochloride on blood level of phosphate, Ca, ph, bicarbonate and gastrointestinal complications in patients undergoing maintenance hemodialysis
Public title
Comparing the effect of sevelamer carbonate and sevelamer hydrochloride on blood level of phosphate, Ca, ph, bicarbonate and gastrointestinal complications in patients undergoing maintenance hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo dialysis three sessions each week for four hours each day.
Their blood phosphorus level is higher than 5.5 mg / dL.
Exclusion criteria:
Patients who have not taken limited Phosphorus diet.
Patients who lose their ability to participate during the study
Patients who are absent from dialysis session
Patients who break their access for some reason
Patients who have taken the medication inappropriately.
Patients with a history of primary hyperparathyroidism or history of parathyroidectomy.
Patients with a history of gastrointestinal diseases include peptic ulcer, reflux, and constipation
Patients with a history of congestive heart failure (due to electrolyte imbalance)
Patients with chronic obstructive pulmonary disease (COPD) (due to acid and basis disorders).
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
patients were randomized with block randomization method individually.First, patients are matched in terms of age, sex, and level of phosphorus and other variables listed in the criteria for entry and exit, in 4 blocks, each block containing 11 patients. randomization was done by sealed envelopes by a third blinded person who was not one of the researchers.
Blinding (investigator's opinion)
Single blinded
Blinding description
patients and data analyzer were unaware of the type of drugs. drugs were bottled in coded bottles with only the investigator knowing which code refers to which intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Khorramshahr Street
City
Zanjan
Province
Zanjan
Postal code
4515613113
Approval date
2017-07-04, 1396/04/13
Ethics committee reference number
ZUMS.REC.1396.122
Health conditions studied
1
Description of health condition studied
Calcium, Phosphorus, PH, Bicarbonate and Gastrointestinal Complications in Hemodialysis Patients
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)
Primary outcomes
1
Description
Blood Calcium
Timepoint
at beginning of intervention and 1 month later
Method of measurement
measurement will be carried out by hospital laboratory
2
Description
blood Phosphorus
Timepoint
at beginning of intervention and 1 month later
Method of measurement
measurement will be carried out by hospital laboratory
3
Description
Blood pH
Timepoint
at beginning of intervention and 1 month later
Method of measurement
measurement will be carried out by hospital laboratory
4
Description
Blood Bicarbonate levels
Timepoint
at beginning of intervention and 1 month later
Method of measurement
measurement will be carried out by hospital laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 800 mg Sevelamer Carbonate triple time daily with each meal for 1 month
Category
Treatment - Drugs
2
Description
Intervention group 2: Sevelamer Hydrochloride 800 mg triple daily with each meal for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital in Zanjan
Full name of responsible person
Bahareh Halisalimi
Street address
Dr. Shariati Street
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
baharehajisalimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Khorramshahr Street
City
Zanjan
Province
Zanjan
Postal code
4515413113
Phone
+98 24 3342 0677
Email
Shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Behrooz Fazeli
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shariati St., Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 919 674 7560
Email
dr.behroozfazeli@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behrooz Fazeli
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shariati St., Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 919 674 7560
Email
Dr.behroozfazeli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behrooz Fazeli
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shariati St., Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 919 674 7560
Email
Dr.behroozfazeli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available