Evaluation renoprotective effect of SGLT2 inhibitors on prognosis of kidney transplant.
Design
This is a randomized clinical trial with parallel control group; triple blind, phase 3 on 30 patients. For randomization, it was performed base on even or odd of national code.
Settings and conduct
The present study will be conducted as a triple blind clinical trial. The patient, the researcher and the analyst will not be aware of the treatment group of the patients. The research community includes patients with diabetic kidney transplant. The research sample includes patients with diabetic kidney transplant who refer to the medical education center Shariati, Tehran, Iran. 30 patients will be selected and included in the study based on the entry and exit criteria.
Participants/Inclusion and exclusion criteria
Inclution criteria:
Age>18 y
Stable renal function for three months-
Consent of patient
Sustained immunosuppressive therapy for three months-
Transplantation > 1 y
Diabetic patient according to criteria of American Diabetes Association
Exclution criteria:
Surgery or medical conditions that affect of Absorption,Distribution- Metabolism or Excretion of drug-
More than one transplant-
Pregnancy or Breastfeeding-
Allergy or Contraindications-
Type 1 diabetes-
Participation in any clinical study within 3 months before initial drug-
GFR < 45-
Frequent UTI-
History of Alcohol use in12 months prior to initial drug-
Donating blood or loss of 400 ml of blood 8 weeks before initial drug
Intervention groups
Intervention group: evaluation of drug effects on kidney function(GFR-Cr) and possible side effects.
Control group: evaluation of effects of placebo.
Main outcome variables
Body mass index(BMI); blood pressure(BP); HbA1c; fasting blood sugar(FBS); glomerular filtration rate(GFR); Hb; Hct; Uric acid; Na; K; creatinin
General information
Reason for update
Acronym
SGLT2 I
IRCT registration information
IRCT registration number:IRCT20220708055414N1
Registration date:2023-02-19, 1401/11/30
Registration timing:retrospective
Last update:2023-02-19, 1401/11/30
Update count:0
Registration date
2023-02-19, 1401/11/30
Registrant information
Name
fattemeh jalali khalil abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 1000
Email address
fattemeh.jalali@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2023-02-18, 1401/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Renoprotective Effect SGLT2 inhibitors on Prognosis of Transplant Kidney Patients
Public title
Evaluation Renoprotective Effect SGLT2 inhibitors on Prognosis of Transplant Kidney Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age>18 years old
Stable state of renal function for at least the last three months
Consent to participate in the study
Sustained immunosuppressive therapy for at least three months
Transplantation > one year ago
Diabetic patient according to the criteria of the American Diabetes Association
Exclusion criteria:
Surgery or medical conditions that affect the rate of Absorption,Distribution and Metabolism or Excretion of the drug
More than one transplant
Pregnancy or Breastfeeding
Allergy or Contraindications
Type 1 diabetes
Participation in any clinical study within 3 months before the initial dose
GFR>45
Frequent UTI
History of Alcohol use in the 12 months prior to the initial dose
Donating blood or Removing 400 ml of blood is required 8 weeks before the initial dose
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly divided into two groups based on whether the last digit of the patient's national code is even or odd
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: People who were invited to participate in the study and after full explanations about the design and obtaining informed consent were divided into two intervention and control groups based on whether the national number was even or odd.
Researcher: I, who aim to investigate the renoprotective effects of SGLT2 inhibitors on kidney transplant patients, and I am also responsible for collecting data and preparing the draft, without knowing whether the patient's medication box is a drug or a placebo based on the criteria for entering and exiting the box. Medicines were provided to patients.
Data analyst: one of the statisticians of the center who analyzes the data according to the numbers of the groups and does not know the control and intervention groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Medicine, Tehran University of Medical Sciences
Street address
Faculty of Medicine, North Gate of University, Porsina St., Quds St., Elkhebal St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-07-02, 1400/04/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.423
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11.2
ICD-10 code description
Type 2 diabetes mellitus with kidney complications
2
Description of health condition studied
Transplant Kidney
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Function of transplant kidney
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Glomerular filteration rate-Creatinine(lab test)
Secondary outcomes
1
Description
FBS
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
2
Description
Hb A1C
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
3
Description
Hemoglobin
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
4
Description
Hematocrite
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
5
Description
uric acid
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
6
Description
Na
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
7
Description
Potasium
Timepoint
At the beginning of the study-End of 8th 16th 24th week
Method of measurement
Laboratory biochemical tests
Intervention groups
1
Description
Intervention group: The group that takes Empagloflozin tablets 10 mg daily for 24 weeks
Category
Treatment - Drugs
2
Description
Control group: The group that takes Plasebo(lactose monohydrate) tablets daily for 24 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Fatemeh Jalali
Street address
Shariati hospital, North Kargar Street, Jalal AlAhmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://Shariati.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Orchidpharmed
Full name of responsible person
Dr Araz Sabzevari
Street address
Number 42, Attar Square, Vanak Square
City
tehran
Province
Tehran
Postal code
1994766411
Phone
+98 21 4347 3000
Fax
+98 21 4347 3000
Email
Info@orchidpharmed.com
Web page address
http://Orchidpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Orchidpharmed
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Jalali
Position
flowship
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Jalal AlAhmad Highway
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://Shariati.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fattemeh Jalali
Position
flowship
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Jalal AlAhmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fattemeh Jalali
Position
flowship
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati hospital, North Kargar Street, Jalal AlAhmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir
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