Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment of children with NEPHROTIC SYNDROM resistance to STEROID that referred to Hazrate Massumeh hospital .
Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment of children with NEPHROTIC SYNDROM resistance to STEROID
Design
102 patients with Steroid-Resistant Nephrotic Syndrome were randomly divided into two groups and each group received a drug, and in parallel, each group was examined.
Settings and conduct
Qom hazrat Masoomeh hospital
Participants/Inclusion and exclusion criteria
All pationts whit NEPHROTIC SYNDROM resistance to STEROID
Intervention groups
Patients with steroid resistant nephrotic syndrome were divided into two groups. The first group received cyclophosphamide and the second group received rituximab.
Main outcome variables
Frequent relapses; Steroid dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170527034146N2
Registration date:2019-02-18, 1397/11/29
Registration timing:retrospective
Last update:2019-02-18, 1397/11/29
Update count:0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
mohsen akhavansepahi
Name of organization / entity
Hazrat massomeh hospital
Country
Iran (Islamic Republic of)
Phone
+98 25 3665 1802
Email address
makhavan@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-09-23, 1397/07/01
Scientific title
Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment of children with NEPHROTIC SYNDROM resistance to STEROID that referred to Hazrate Massumeh hospital .
Public title
Evaluation of the occurrence, effect and side effects oFcyclophosfamid and rituximab in the tratment of children with NEPHROTIC SYNDROM resistance to STEROID that referred to Hazrate Massumeh hospital .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAll patient whit nephrotic syndrome resistance to steroid whit age 1-18 yr
Exclusion criteria:
All patient who do not have steroid-resistant Nephrotic Syndrome for example patient with steroids depended syndrome.
All patient who did not accept treatment
All patient who died
All patient who did not follow up
Age
From 1 year old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
The simple random sampling method was used for the selected sample and was divided into two groups of intervention and control by simple randomized distribution method. The randomized random number tool is the unit of individual cadastre. The patients were divided into two equal groups, regardless of sex and age, and on the basis of resistant to steroid therapy.The intervention group, in addition to prednisolone, received Ritoximab, which received a cyclophosphamide drug control 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 QOM University of Medical Sciences
Street address
EMAM STREET.
City
QOM
Province
Ghoum
Postal code
3719815532
Approval date
2017-09-05, 1396/06/14
Ethics committee reference number
IR.MUQ.REC.1396.77
Health conditions studied
1
Description of health condition studied
Nephrotic syndrome resistance to steroide
ICD-10 code
N04.8
ICD-10 code description
Nephrotic syndrome with other morphologic changes
Primary outcomes
1
Description
The frequency of relapse of the disease before and after taking the cyclofosfamide and ritoximab
Timepoint
Weekly
Method of measurement
Urin analysis of proteine
2
Description
Dosage of the prednisolon before and after taking the medication
Timepoint
weekly
Method of measurement
check liste
Secondary outcomes
1
Description
Number of relapses after receiving rutioxime and cyclolophosphamide.
Timepoint
weekly
Method of measurement
Urinalysis. Patient's disease
2
Description
Dosage of Steroids after receiving medication
Timepoint
weekly
Method of measurement
check liste
Intervention groups
1
Description
Intervention group:I ntervention group: In addition to prednisolone, ritoximab with 375 mg / m 2 / day was given intravenously and weekly for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group: Control group: In addition to prednisolone, cyclosfamide dose of 2 mg per kg per day For three months