Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients during a clinical trial at Imam Reza Educational and Medical Center in Kermanshah
Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients
Design
This study is a single-blinded clinical trial with a parallel design and a control group. The study population will include all patients with kidney transplantation referred to Imam Reza (AS) Hospital in Kermanshah. 28 eligible people will be selected conveniently. Random blocks are used for randomization and participants are assigned to two groups of intervention and control.
Settings and conduct
This study is a single-blinded clinical trial. In this study, participants will be unaware of the allocation of study groups and the dose of received medication. Participants do not know which group will receive the new drug or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Urinary protein excretion less than (<) 500 mg to 3500 mg / g in a 24-hour urine set; Kidney transplant equal to or greater than 1 year ago; Stable state of renal function for at least the last three months; Sustained immunosuppressive therapy for at least the last 3 months
Exclusion criteria:Creatinine above 2; Patients who are pregnant or are breastfeeding; Patients with a history of type 1 diabetes; History of more than one kidney transplant; History of severe allergies or contraindications to empagliflozin; History of recurrent urinary tract infection
Intervention groups
The intervention group will receive empagliflozin at a dose of 10 mg daily with routine treatment (500 mg metformin two or three times daily). The control group will receive 10 mg of placebo daily (similar in appearance to empagliflozin) with routine treatment (500 mg of metformin two or three times daily).
Main outcome variables
Serum creatinine, urinary protein content
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N168
Registration date:2021-05-10, 1400/02/20
Registration timing:registered_while_recruiting
Last update:2021-05-10, 1400/02/20
Update count:0
Registration date
2021-05-10, 1400/02/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-09, 1400/02/19
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients during a clinical trial at Imam Reza Educational and Medical Center in Kermanshah
Public title
Comparison of the renoprotective effects of SGLT2 inhibitor (Empagliflozin) in diabetic and non-diabetic kidney transplantation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Urinary protein excretion less than (<) 500 mg to 3500 mg / g in a 24-hour urine set
Kidney transplant equal to or greater than 1 year ago
Stable state of renal function for at least the last three months
Sustained immunosuppressive therapy for at least the last 3 months
Exclusion criteria:
Creatinine above 2
Patients who are pregnant or are breastfeeding
Patients with a history of type 1 diabetes
History of more than one kidney transplant; History of severe allergies or contraindications to empagliflozin
History of recurrent urinary tract infection
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups . Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blinded study, participants will be unaware of the allocation of study groups and the dose of received medication. Participants do not know which group will receive the new drug or placebo.
Placebo
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 Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
ir.kums.rec.1399.1173
Health conditions studied
1
Description of health condition studied
kidney transplantation
ICD-10 code
T86.1
ICD-10 code description
Complications of kidney transplant
Primary outcomes
1
Description
Serum creatinine
Timepoint
The beginning of the study, the end of the 4th week, the end of the 8th week and the end of the 12th week
Method of measurement
Blood test
2
Description
Urine protein content
Timepoint
The beginning of the study, the end of the 4th week, the end of the 8th week and the end of the 12th week
Method of measurement
urine test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group for 12 weeks will receive empagliflozin at a dose of 10 mg daily with routine treatment (500 mg metformin two or three times daily).
Category
Treatment - Drugs
2
Description
The control group for 12 weeks will receive 10 mg of placebo daily (similar in appearance to empagliflozin) with routine treatment (500 mg of metformin two or three times daily).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyed Mohammad Mostafavi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
dr.mostafavi97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@mbrc.ac.ir
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
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
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mostafavi
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
dr.mostafavi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Abdi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
dr.mostafavi97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mostafavi
Position
Resident of Urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
dr.mostafavi97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD