In this study, patients with Idiopathic membranous nephropathy who refer to special clinic of Kermanshah University of Medical Sciences will investigate. These patients will divide into two equal groups randomly that will match for age and sex. Patients of each group will threat with Cyclosporine or Tacrolimus. After 3 and 6 month of treatment, results of laboratory tests including 24 hours urine protein, urea, creatinine, uric acid, triglyceride and fasting blood sugar will compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101912685N3
Registration date:2014-11-26, 1393/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-26, 1393/09/05
Registrant information
Name
Hamidreza Omrani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6302
Email address
hamidomrani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of Tacrolimus and cyclosporine in patients with Idiopathic membranous nephropathy
Public title
Comparison of effect of Tacrolimus and cyclosporine in patients with autoimmune nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Idiopathic membranous nephropathy had been confirmed by kidney biopsy; Patients have proteinuria more than 3000 mg per day. Exclusion criteria: Patients with secondary Idiopathic membranous nephropathy; Patients with sensitivity to Tacrolimus.
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Chancellery of Research & Technology, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-07-07, 1393/04/16
Ethics committee reference number
9838
Health conditions studied
1
Description of health condition studied
Idiopathic membranous nephropathy
ICD-10 code
N03
ICD-10 code description
Chronic nephritic syndrome
Primary outcomes
1
Description
Urine protein
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Urine biochemistry test
2
Description
Kidney biopsy
Timepoint
Before intervention
Method of measurement
Kidney biopsy test
3
Description
Blood urea
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Blood biochemistry test
4
Description
Blood creatinin
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Blood biochemistry test
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Blood biochemistry test
2
Description
Blood triglyceride
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Blood biochemistry test
3
Description
Blood cholesterol
Timepoint
Before intervention, after 3 month of intervention and after 6 month of intervention
Method of measurement
Blood biochemistry test
Intervention groups
1
Description
Intervention group: Tacrolimus for 6 month with dose of 0.5 mg/kg/day
Category
Treatment - Drugs
2
Description
Control group: Cyclosporine for 6 month with dose of 6 mg/kg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of Kermanshah University of Medical Sciences
Full name of responsible person
Hamid Reza Omrani
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellery of Research & Technology, 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
Hamid Reza Omrani
Position
Specialist in nephrology
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3837 0557
Fax
Email
hamidomrani@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
Hamid Reza Omrani
Position
Specialist in nephrology
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 3837 0557
Fax
Email
hamidomrani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)