Evaluation of tolerance and safety of empagliflozin in children with non-diabetic proteinuria
Design
The current study is a phase 1 clinical trial study and will be conducted in children with non-diabetic proteinuria aged 5 to 17 years. In this study, patients will receive the usual treatment regimen along with Empagliflozin at the beginning with a dose of 5 mg for 3 months and then 10 mg per day for another 3 months (for a total of 24 weeks). This study is a study. It is a pilot and the data collection method is laboratory, observation and interview, and the collection tool will be a questionnaire, and the resulting data will be evaluated using SPSS software.
Settings and conduct
This study is a clinical trial and is conducted at Ali Asghar Children's Hospital.
Participants/Inclusion and exclusion criteria
- Study population:
1-1- Criteria for entering the study:
1- Age 5 to 17 years
2- Suffering from non-diabetic proteinuria according to the diagnosis of a nephrologist
3- Receiving a clinically appropriate dose of ACEIs or ARBs unless the treatment is intolerable or has no indication.
4- GFR more than 60 ml/min
1-2- Exclusion criteria from the study:
1- Suffering from moderate to severe liver failure
2- Type 1 and 2 diabetes
3- Allergy to any component of the drugs used
4- Hypotension
5- Receiving immunosuppressants during the last 6 months
6- Polycystic kidney disease
7- Poor compliance of the patient during the visits regarding the drugs used
8- Kidney transplant
9- Simultaneous reception of ACEIs or ARBs
Intervention groups
After entering the study, patients will be treated with the usual treatment regimen plus empagliflozin at a daily dose of 5 mg for 12 weeks. Then, if tolerated, the dose will be increased to 10 mg per day and the treatment will continue for another 3 months (24 weeks in total).
Main outcome variables
Change in eGFR
Change in weight
Changes in blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220405054414N1
Registration date:2023-08-27, 1402/06/05
Registration timing:registered_while_recruiting
Last update:2023-08-27, 1402/06/05
Update count:0
Registration date
2023-08-27, 1402/06/05
Registrant information
Name
Mohammadreza Maghamipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 5019
Email address
mmaghami11@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to assess the safety and tolerability of the SGLT2 inhibitor empagliflozin on proteinuria in non-diabetic patients
Public title
The effect of empagliflozin on proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 5 to 17 years old
Suffering from non-diabetic proteinuria according to the diagnosis of a nephrologist
Receiving a clinically appropriate dose of ACEIs or ARBs unless treatment is not tolerated or indicated
GFR more than 60ml/min
Exclusion criteria:
Moderate to severe liver failure
Having type 1and 2 diabetes
Sensitivity to any of the components of the drugs used
Hypotension
Receiving immunosuppressants in the last 6 months
Having Polycystic kidney disease
Poor patient compliance during medication visits
Kidney transplant
Concurrent administration of ACEIs or ARBs
Age
From 5 years old to 17 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Iran medical university, Hemmat highway, milad tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.IUMS.REC.1402.050
Health conditions studied
1
Description of health condition studied
Proteinuria
ICD-10 code
R80.1
ICD-10 code description
Persistent proteinuria, unspecified
Primary outcomes
1
Description
change in body measurement
Timepoint
baseline to 24 weeks
Method of measurement
scales
2
Description
change in blood pressure
Timepoint
baseline to 24 weeks
Method of measurement
Pressure gauge device
3
Description
change in eGFR
Timepoint
baseline to 24 weeks
Method of measurement
schwartz method
4
Description
change in glycemic control
Timepoint
baseline to 24 weeks
Method of measurement
blood draw from vein
5
Description
time to the first occurrence of urinary infection
Timepoint
baseline to 24 weeks
Method of measurement
urine analysis
6
Description
time to first occurrence of AKI
Timepoint
baseline to 24 weeks
Method of measurement
SCr
Secondary outcomes
1
Description
Change from baseline in proteinuria
Timepoint
Baseline to ۲۴ weeks
Method of measurement
Urin analysis
Intervention groups
1
Description
Intervention group: All non-diabetic proteinuria patients aged 5 to 17 years are first given half a tablet of empagliflozin 10 mg (Gloripa manufactured by Abidi company) for 3 months, and if they tolerate it for another 3 months, they are given a full tablet .
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
No - There is not 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 collected deidentified IPD
When the data will become available and for how long
One year after publication
To whom data/document is available
available for people working in academic institute
Under which criteria data/document could be used
Using the information by the principle investigators for the use in other research work
From where data/document is obtainable
Parastoo Mirzabeygi
pmirzabeygi@gmail.com
What processes are involved for a request to access data/document
1 year after publication, the principal investigator oh the other studies with academic position can request for data sharing from the principal investigator of the current study