Evaluation of Mycophenolate Mofetil and Prednisolone Effect as Initial Treatment on Idiopathic Membranous Nephropath
Design
In randomized single blinded phase 3 clinical trial study 30 patient divided in two groups.Sampling was done by randomized block sampling and the subjects were randomly assigned to each of the groups. 17 patient received Mycophenolate mofetil and 13 patient received cyclophosphamide for 6 months.
Settings and conduct
This study was conducted on 30 patients in Ahvaz Golestan hospital as blind study and the person who evaluated patient didn't know the kind of drug
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with nephrotic syndrome with more than 4 gr / d of proteins in 24-hour urine or changes in GFR (increase more than 30% without a known cause) and change in serum creatinine, patients with severe and disabling symptoms associated with nephrotic syndrome.
Exclusion criteria: Patients with systemic disease, malignancy, active infection, infertility, unstable angina pectoris, type I and type II diabetes, clinical evidence of renal vein thrombosis, acute gastric ulcer or gastrointestinal disease that disturbs the absorption of oral medications.
Intervention groups
Mycophenolate mofetil group,
Prednisolone group
Main outcome variables
Urine protein, Albumin, Blood cholesterol and Blood creatinin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180128038539N1
Registration date:2018-03-09, 1396/12/18
Registration timing:retrospective
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Shahla Ahmadi halili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 3500
Email address
ahmadihalili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-07-16, 1393/04/25
Expected recruitment end date
2018-01-17, 1396/10/27
Actual recruitment start date
2014-07-16, 1393/04/25
Actual recruitment end date
2018-01-17, 1396/10/27
Trial completion date
empty
Scientific title
Evaluation of mycophenolate mofetil and prednisolone effect as initial treatment on idiopathic membranous nephropathy
Public title
Evaluation of mycophenolate mofetil and prednisolone effect as initial treatment on idiopathic membranous nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with nephrotic syndrome with more than 4 gr / d of proteins in 24-hour urine
changes in GFR by increase more than 30% without a known cause in serum creatinine level
patients with severe and disabling symptoms associated with nephrotic syndrome
Exclusion criteria:
systemic disease
malignancy
active infection
pregnancy
unstable angina pectoris
type I and type II diabetes
clinical evidence of renal vein thrombosis
acute gastric ulcer or gastrointestinal disease that disturbs the absorption of oral medications
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups by randomized blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind. the person who evaluated patient don't know the kind of drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran Ahvaz Khuzestan Iran, Islamic Republic Of
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2014-10-11, 1393/07/19
Ethics committee reference number
ajums.REC.1393.226
Health conditions studied
1
Description of health condition studied
Chronic nephritic syndrome
ICD-10 code
N03
ICD-10 code description
Chronic nephritic syndrome
Primary outcomes
1
Description
Urine protein
Timepoint
Before intervention and after 2, 4 and 6 month of intervention
Method of measurement
Urine biochemistry test
2
Description
Albumin
Timepoint
Before intervention and after 2, 4 and 6 month of intervention
Method of measurement
Urine biochemistry test
3
Description
Blood cholesterol
Timepoint
Before intervention and after 2, 4 and 6 month of intervention
Method of measurement
Blood biochemistry test
4
Description
Blood creatinin
Timepoint
Before intervention and after 2, 4 and 6 month of intervention
Method of measurement
Blood biochemistry test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mycophenolate mofetil with a dose of 1 g every 12 hours for 6 months and prednisolone 0.5 mg/kg/d for 3 months
Category
Treatment - Drugs
2
Description
Control group: Oral cyclophosphamide with a dose of 1.5 mg/kg/d for 6 months and prednisolone 0.5 mg/kg/d for 6 months