Effect of Linagliptin on proteinuria in diabetic patients with chronic kidney disease
Design
Randomized double blinded clinical trial with a parallel group design of 140 patients, enrolled between March 2019 and May 2020
Settings and conduct
All allocated participants are enrolled in study, after filling satisfaction in a hospital & a private clinic. they receive drug or placebo blindly.
Participants/Inclusion and exclusion criteria
Inclusion: Have Diabetes Mellitus, eGFR between 30-60cc/min/1.73m2 , Proteinuria more than 300mg/d , Not use Immunosuppressive drugs( cyclosporin, tacrolimus, mycophenolate, azathioprin, methotrexate), inactive urine sediment
Exclusion: Changes in drug doses of proteinuria like Angiotensin converting enzyme inhibitors, Angiotensin receptor blockers, Diltiazem, statins, Drug complications like cough, sore throat, myalgia and uncooperative patients
Intervention groups
Patients are taken Linagliptin 5 mg manufactured by Alhavi pharmaceutics for 6 months. they do laboratory examination at months 3 & 6. patients in control group are taken placebo drug, manufactured by Alhavi pharmaceutics and do laboratory examination after months 3 & 6.
Effect of Linagliptin on Proteinuria in Diabetic Renal Disease patients
Public title
Effect of Linagliptin on diabetic proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes Mellitus
eGFR between 30-60cc/min/1.73m2
Proteinuria more than 300mg/d
Not use Immunosuppressive drugs( cyclosporin, tacrolimus, mycophenolate, azathioprin, methotrexate)
inactive urine sediment
Exclusion criteria:
Hypoglycemia
HbA1C less than 6%
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The numbers are divided to 2 groups: study and placebo according to table of random numbers via software. this numbers have 4 parts. First participate receive first 4 digit number, second person receive second 4 digit number and .....They receive drug or placebo according to codes. The study is a double blind because the patients and coordinator do not know there is drug or placebo. Principal investigator design random numbers and get to coordinator. Only principal investigator know which package is drug or placebo and he do not have any role in data analysis.It is a double blind study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug & placebo will be given to care provider. these drugs are similar together and are given to participant. care provider & participant are blinded about drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Sofe Ave. Isfahan Kidney Diseases Research Center, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.196
Health conditions studied
1
Description of health condition studied
Proteinuria in diabetic patients with chronic kidney disease
ICD-10 code
E08.22
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic chronic kidney disease
Primary outcomes
1
Description
proteinuria
Timepoint
before intervention and 3 & 6 months later
Method of measurement
urine 24 hours collection
Secondary outcomes
1
Description
serum creatinin
Timepoint
before intervention and 3 & 6 months later
Method of measurement
laboratory kit ELISA
2
Description
systolic blood pressure
Timepoint
before intervention and 3 & 6 months later
Method of measurement
Digital sphygmomonometer
3
Description
diastolic blood pressure
Timepoint
before intervention and 3 & 6 months later
Method of measurement
Digital sphygmomonometer
4
Description
Hemoglobin A1C
Timepoint
before intervention and 3 & 6 months later
Method of measurement
laboratory kit ELISA
5
Description
fasting blood suger
Timepoint
before intervention and 3 & 6 months later
Method of measurement
laboratory kit
Intervention groups
1
Description
Intervention group: Linagliptin ( Melijent), Linagliptin molecule, 5mg tablet, one tablet daily for 6 months, irrespective to diet, manufactured by Alhavi pharmaceutic, IRAN
Category
Treatment - Drugs
2
Description
Control group: Placebo tablet, 5 mg, daily for 6 months, manufactured by Alhavi pharmaceutic, IRAN
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzaha hospital
Full name of responsible person
Firouzeh Moeinzadeh
Street address
Sofe Ave. Alzahra hospital, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 6713
Email
fimoinzad@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Mojgan Mortazavi
Street address
Azhand building, Amadegah Av, Isfahan, IRAN
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 6713
Email
m_mortazavi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoy Javanmard
Street address
Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@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
10
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
Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 6713
Email
f_moinzade@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 6713
Email
fimoinzad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe street, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 6713
Email
fimoinzad@yahoo.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
Analyzed data will be available
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
In response to requests via email sending, only analysis and results will send to person via person responsible for scientific inquiries. Using the analysis without reference indicating is forbidden. email: fimoinzad@yahoo.com
From where data/document is obtainable
Requests via email sending to person responsible for scientific inquiries address: fimoinzad@yahoo.com .
What processes are involved for a request to access data/document