The aim of this study is to evaluate the effect of melatonin on ischemia-re perfusion injury( IRI) and expression of Klotho protein in kidney transplant patients. The Study included 80 kidney transplant recipients,recruited based on inclusion and exclusion criteria of our study. All the patients should have had been a history of dialysis at least three months. Smoking and cancerous patients were also excluded from the study. Patients were randomly divided into two groups including control group and trial group. In current study all patients are monitored before and after melatonin administration with use of blood samples. primary Blood samples will be collected 28 days before melatonin and placebo administration.Then the trial group will received melatonin and a a placebo will administered to the control group with dose of dose of 3mg/day for 4 weeks. As secondary blood samples will be taken 24 hours after surgery.Finally in both groups the serum level of TNF-α ,NGAL ,nuclear activity rate of NFKB and the expression of klotho are measured and compared with use of blood samples.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610203812N5
Registration date:2016-11-26, 1395/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Amir Ghorbanihaghjo
Name of organization / entity
Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz 51664, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3234
Email address
ghorbani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Melatonin on ischemia-reperfusion injury and the klotho protein expression in renal transplant patients
Public title
Effects of Melatonin on injury caused by transplant process in renal transplant patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: kidney transplant candidate؛ had a history of dialysis at least 3 months.
Exclusion criteria :Patients with inflammatory disease؛ acute or chronic infection؛ autoimmune diseases؛ hepatic insufficiency ؛ diabetes؛ malignancy ؛depression ؛ high and low pressure ؛ seizures ؛ smokers
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Science
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.TBZMED.REC 1395.756
Health conditions studied
1
Description of health condition studied
Kidney Transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
TNF-a
Timepoint
3 month
Method of measurement
ELISA
2
Description
nulear NFKB activity
Timepoint
3 month
Method of measurement
ELISA
3
Description
oxidative stress factors
Timepoint
3 month
Method of measurement
spectrophotometric methods
Secondary outcomes
1
Description
klotho gene and protein expression
Timepoint
3 month
Method of measurement
Real-time PCR and western blotting
Intervention groups
1
Description
The trial group will be administered oral melatonin at the dose of 3mg/day for a period of 28 days before kidney transplant.
Category
Prevention
2
Description
The control group will received oral placebo at the dose of 3mg/day for a period of 28 days before kidney transplant.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Research Center
Full name of responsible person
Dr Hassan Argani
Street address
Nephrology Research Center, Shahid Modarress Eeducational Hospital,Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences, Biotechnology Research Center
Full name of responsible person
Dr Siavoush Dastmalchi
Street address
Biotecnology Research Center, Daneshgah Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences, Biotechnology Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Nephrology Research Center
Full name of responsible person
Dr Hassan Argani
Street address
Nephrology Research Center, Shahid Modarress Eeducational Hospital,Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Hassan Argani
Position
professor of Nephrology
Other areas of specialty/work
Street address
nephrology reaserch center,Shahid Modarress Educational Hospital,Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2208 3118
Fax
Email
hassanargani@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabrize University of Medical Science
Full name of responsible person
Dr Amir Ahorbanihaghjo
Position
Clinical Biochemistry, PhD
Other areas of specialty/work
Street address
Department of Clinical Biochemistry, Medical Faculty, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3336 3231
Fax
Email
ghorbaniamir@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabrize University of Medical Science
Full name of responsible person
Fatemeh Panah
Position
PhD student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)