Treatment of frequently relapsing (FR) or steroid dependent(SD) idiopathic nephrotic syndrome remains a great challenge because of prolonged courses of steroid use with potential for serious complications. Some drugs, including cyclophosphamide, cyclosporine, chlorambucil, MMF, have been used as second line drugs to reduce the dose of corticosteroids; but most of them have serious complications. Levamisole, an antihelminthic drug has been used as steroid-sparing agent in idiopathic nephrotic syndrome. Regarding to fewer complications of levamisole in comparison with other steroid-sparing drugs, effectiveness of levamisole in reducing the number of relapses and cumulative dose of steroid in FRNS and SDNS would let to use it as the first line steroid-sparing agent. Our study is a before-after clinical trial in which we evaluate the effectiveness of levamisole in thirty 1-14 year old patients with frequently relapsing or steroid dependent idiopathic nephrotic syndrome. Patients will be treated with prednisolone 40 mg/m2/day in their relapse episode till remission is acheived, then Levamisole 2.5 mg/kg every other day will be administered and the dose of prednisolone will be continued with the dose of 0.5-1 mg/kg every other day .Prednisolone will be tapered gradually untill it can be discontinued or the least effective dose for control of relapses is achieved. Level of proteinuria and clinical signs will be evaluated every 1-2 months. Liver function tests and CBC will be assessed every 4 months. Then relapse rate (relapse/year) and cumulative dose of prednisolone (mg/m2/year)will be compared before and after the beginning of levamisole.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106066589N2
Registration date:2011-08-15, 1390/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
abolhassan seyedzadeh
Name of organization / entity
kemanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 831427630108
Email address
asayedzadeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology; Kermanshah University of Medical Sciences
Expected recruitment start date
2010-09-21, 1389/06/30
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of levamizole effect in reduction of relapse rate in children with frequently relapsing/steroid dependent idiopathic nephrotic syndrome
Public title
Levamizol effect in reducing relapse rate of nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: idiopathic nephrotic syndrome;frequent relapses or dependency to steroid;age 1-14 years old. Exclusion criteria: the patients who consume levamizole less than 6 months;need to start other immunosupressive drugs to control the relapses.
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2011-01-15, 1389/10/25
Ethics committee reference number
7/420/1800450
Health conditions studied
1
Description of health condition studied
nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Primary outcomes
1
Description
rate of relapses of nephrotic syndrom
Timepoint
during the whole period of study
Method of measurement
in relapses/year
2
Description
cumulative dose of prednisolone
Timepoint
durig the whole period of the study
Method of measurement
in mg/kg body weight/year
Secondary outcomes
1
Description
neutropenia
Timepoint
every 4 months
Method of measurement
CBC
2
Description
liver enzymes elevation
Timepoint
every 4 months
Method of measurement
AST,ALT
3
Description
seizure
Timepoint
during the study period
Method of measurement
clinical
Intervention groups
1
Description
In patients with relapse of NS,the relapse episode is controled with prednisolone 40 mg/m2/day for 7-10 days and then levamisole 2.5 mg/m2/every other day is administered while prednisolone is tapered gradually.This two drugs are continued untill prednisolone can be discontinued or the side effects of levamisole happen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Vice-Chancellor of Research and Technology
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Abolhassan Seyedzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Nephrology and Urology Research Centre, Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6301
Fax
Email
asayedzadeh@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of Medical Sciences
Full name of responsible person
Dr Abolhassan Seyedzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Nephrology and Urology Research Centre, Imam Reza Hospital
City
Kermanshah
Postal code
67148
Phone
+98 83 1427 6301
Fax
Email
asayedzadeh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bita Alimardani
Position
Pediathric Resident
Other areas of specialty/work
Street address
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)