The effect of mycophenolate mofetil in controlling the recurrence of idiopathic nephrotic syndrome in steroid-dependent children or frequent recurrence in patients referred to pediatric nephrology clinic, Imam Reza hospital
The effect of mycophenolate mofetil in controlling the recurrence of idiopathic nephrotic syndrome in steroid-dependent children or frequent recurrence in patients referred to pediatric nephrology clinic, Imam Reza hospital
Design
This study is a non-blinded clinical trial.The study population will be included all children with steroid-dependent idiopathic nephrotic syndrome or frequent recurrent that referring to pediatric nephrology clinic, Imam Reza hospital of Kermanshah city 2006-2018.12 eligible patients will be selected conveniently and randomly will be assigned to the intervention and control group.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is non-blinded one.At the beginning and the end of the study, digestive complications, infection and leukopenia are recorded in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ages 1 to 12 years
Exclusion criteria:Patients who have been treated with MMF for at least 6 months
Intervention groups
The intervention group will receive MMF in a dose of 600 mg / m2 every 12 hours. Corticosteroid dose of 60mg / m2 increases for three consecutive days until negative proteinuria. The control group will not receive intervention
Main outcome variables
Digestive complications; Infection; Leukopenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N113
Registration date:2019-02-24, 1397/12/05
Registration timing:prospective
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mycophenolate mofetil in controlling the recurrence of idiopathic nephrotic syndrome in steroid-dependent children or frequent recurrence in patients referred to pediatric nephrology clinic, Imam Reza hospital
Public title
The effect of mycophenolate mofetil in controlling the recurrence of idiopathic nephrotic syndrome in steroid-dependent children or frequent recurrence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 1 to 12 years
Exclusion criteria:
Patients who have been treated with MMF for at least 6 months
Age
From 1 year old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-09-11, 1397/06/20
Ethics committee reference number
ir.kums.rec.1397.938
Health conditions studied
1
Description of health condition studied
Nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Digestive complications
Timepoint
The beginning, end of the study and every three months
Method of measurement
Asking the patient
2
Description
Infection
Timepoint
The beginning and end of the study
Method of measurement
Doctor's observation
3
Description
Leukopenia
Timepoint
The beginning and end of the study
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive MMF in a dose of 600 mg / m2 every 12 hours. Corticosteroid dose of 60mg / m2 increases for three consecutive days until negative proteinuria.
Category
Treatment - Devices
2
Description
The control group will not receive intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Parastar Boulevard
Full name of responsible person
Mahdi Rafati
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mrafati41@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice chancellor for research of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahdi Rafati
Position
Resident of child
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mrafati41@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Seyed Abolhasan Seyedzadeh
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
asayedzadeh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahdi Rafati
Position
Resident of child
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mrafati41@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail