Aim of this study is evaluation of Allopurinol on residual renal function in peritoneal dialysis patients.
Design
A randomizsed, blinded clinical trial with a parallel group without placebo use.
Settings and conduct
Peritoneal dialysis patients with hyperuricemia are divided in 2 groups. According to randomized numbers, they are divided to group with drug use and group without drug use. Nurse and investigator are blinded to drug use and patients are visited by physician.
Participants/Inclusion and exclusion criteria
49 patients arrived in study. Inclusion criteria are: peritoneal dialysis at least 3 months, uric acid level more than 7mg/dL in men and more than 6mg/dL in women and residual renal function more than 2cc/min. Exclusion criteria are death, change to hemodialysis, renal transplantation, drug allergy or complication of drug.
Intervention groups
They recieve tablet allopurinol 100 mg manufactured by Jalinous company for 6 months and uric acid level and residual renal function are measured at begining and the end of study. results compare with same patient without drug therapy.
Main outcome variables
determination of residual renal function after drug use.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090905002417N20
Registration date:2018-03-21, 1397/01/01
Registration timing:retrospective
Last update:2018-03-21, 1397/01/01
Update count:0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Allopurinol on renal residual function in hyperuricemic peritoneal dialysis patients
Public title
Effect of Allopurinol on renal residual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
consent for cooperation
peritoneal dialysis for at least 3 months
18-80 years old
hyperuricemia: uric acid level ≥7mg/dL in men and ≥6mg/dL in women
minimum residual renal function : 2cc/min/m2
Exclusion criteria:
death
allopurional allergy or complications
hemodialysis rout for dialysis
renal transplantation
nephrotoxic drug use
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, nurses and investigator are blinded in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
IR.MUI.REC.1395.3.837
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
N18.0
ICD-10 code description
end stage renal disease
Primary outcomes
1
Description
serum uric acid level
Timepoint
before intervention and 6 months after drug use
Method of measurement
laboratory kit- ELISA- with HITACHI equipment
2
Description
residual renal function
Timepoint
before intervention and 6 months after drug use
Method of measurement
renal function formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Allopurinol tablet usage, 100mg daily orally for 6 months manufactured by Jalinous company
Category
Treatment - Drugs
2
Description
Control group: no drug use
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Shirin Karimi
Street address
Alzahra Hospital, Sofe Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
fimoinzad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Movahedian Atar
Street address
Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3668 7898
Email
movahedian@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Elham kabiri
Position
Internal medicine resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Sofe Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
Kabirielham20@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Alzahra hospital, Sofe Avenue. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
fimoinzad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Alzahra hospital, Sofe Avenue. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
Email
fimoinzad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Primary outcome measure could be shared after termination of study.
When the data will become available and for how long
starting 1 year after publication
To whom data/document is available
Academic institution can apply to recieve it
Under which criteria data/document could be used
using data for similar studies
From where data/document is obtainable
get documents by e-mail adress to information provider
What processes are involved for a request to access data/document
After introduce and academic information, please explain your aim(s). they must committal to refer this study as reference if they use data. otherwise we entitle to follow these to Ethic commitee.