Evaluation of effect of spiranolactone on proteinuria in kidney transplant patients
Design
Two arm parallel group randomisedtrial with double blind care and outcome
Settings and conduct
Khorshid hospital,Al Zahra hospital and office
Participants/Inclusion and exclusion criteria
Entrance to study:Three month or more after kidney transplant with proteinuria more than 0.5 gram per day
Not to entrance to study: hypercalemia,sensitivity to drug gynechomastia,usage of drug for heart or liver failure estimated glomerular filtration rate below 30 military liter per minute
Intervention groups
Kidney transplant patients with proteinuria of more than 0.5 gram per day.For the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and will be prescribed for a total of four months, and for the patients in the second group as the control group, placebo tablets will be prescribed for four months. becomes
Main outcome variables
Proteinuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230516058205N1
Registration date:2023-07-06, 1402/04/15
Registration timing:registered_while_recruiting
Last update:2023-07-06, 1402/04/15
Update count:0
Registration date
2023-07-06, 1402/04/15
Registrant information
Name
Pejman Poorshabanan najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1396
Email address
pejmanpoorshabanan@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of spironolactone on proteinuria in kidney transplant patients
Public title
Evaluation of effect of spironolactone on proteinuria in kidney transplant patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Persons with more than three months after kidney transplantation
Proteinuria more than 0.5 gram per day
Estimated glomerular filtration rate more than 30 mili liter per minute
Consent to participate in study
Exclusion criteria:
Serum potassium more than 5.5
Gynechomastia
Transplant dysfunction(eGFR<30)
Spironolactone usage for heart and liver failure
sensitivity to spironolactone
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, random allocation software and block randomization method are used. In this method, 60 eligible patients are randomly divided into 30 blocks including 2 patients. Then, each of the 2 patients in the block randomly receives spironolactone or placebo, so that 30 patients are assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be divided into two groups using random allocation software. Then, for the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and will be prescribed for a total of four months, and for the patients in the second group as the control group, the placebo tablets will be prescribed for four months. It is prescribed. It should be noted that in order to comply with the conditions of blinding, the two drugs spironolactone and placebo are made in advance by the pharmacist (Abourihan Pharmaceutical Company) in the same shape, size and color and are placed in similar packages and labeled A, B at the disposal of the researcher. is placed and without knowing the type of medicine, they prescribe the same in two groups
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfan University of medical sciences
Street address
Heparin jarib
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.ari.mui.rec.1402.021
Health conditions studied
1
Description of health condition studied
Proteinuria
ICD-10 code
N08
ICD-10 code description
Glomerular disorders in diseases classified elsewhere
Primary outcomes
1
Description
Urine protein
Timepoint
Monthly
Method of measurement
24 hours urine sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the patients in the first group as the intervention group, spironolactone 25 mg tablets will be started half daily and after one month it will be increased to one tablet daily and it will be prescribed for a total of four months,
Category
Treatment - Drugs
2
Description
Control group: For the patients in the second group as the control group, the placebo tablets will be administered for four months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Pejman Pourshabanan Najafabadi
Street address
Second apadana Street.welfare organization of Isfahan province
City
Isfahan
Province
Isfehan
Postal code
۸۱۶۶۶۳۷۳۱۶
Phone
+98 31 3641 1391
Email
pejmanpoorshabanan@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
Askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Abdolamir Atapour
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
nephrology
Street address
second apadana street
City
Isfahan
Province
Isfehan
Postal code
8166637317
Phone
+98 31 3641 1396
Email
pejmanpoorshabanan@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abdolamir Atapour
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
nephrology
Street address
ostandari street.Khorshid hospital
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
abdolamiratapour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pejman Poorshabanan Najafabadi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
nephrology
Street address
second apadana street
City
Isfahan
Province
Isfehan
Postal code
8166637317
Phone
+98 31 3641 1391
Email
pejmanpoorshabanan@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be released after making persons unidentifiable.
When the data will become available and for how long
Begining access period time from 1403.
To whom data/document is available
Researchers who are occupying in universities and scientific institutes
Under which criteria data/document could be used
Results of this study can be used in other researches.
From where data/document is obtainable
pejmanpoorshabanan@hotmail.com
What processes are involved for a request to access data/document
One month after receiving request , we will send the results of this study.