Compare changes two subsets of regulatory T cells (Treg) and gene expression of Foxp3, RORγT, T-bet and GATA-3 in kidney transplant patients under two different treatment protocols
Of the 20 patients (two groups of 10 patients each with a different drug protocols) that for various reasons are transplant candidates According to standard protocols under immunosuppressive therapy after transplantation.10 cc of blood from patients before and 4 months after transplantation is taken(In case of rejection of allograft we will measure the biomarkers ). in addition, a list containing demographic, clinical, pharmacology and laboratory for each patient completed.In all samples after purification of mRNA and synthesis of c DNA, gene expression of Foxp3, RORγT, T-bet, and GATA-3 are examined with Real-time PCR technique.The frequency of CD4 + CD25 + FOXP3 + Treg cells and CD8 + CD28- Treg are analyzed by flow cytometry.then we use a statistical method to analysis the correlation between new data and clinical and paraclinical findings.The sensitivity and specificity of biomarkers for the detection of transplant rejection will be checked.so, The aim of this study is the effective treatment to prevent rejection and if we see a significant correlation between the frequency of these cells and the incidence of acute rejection or chronic allograft and clinical findings, we can prophesy the kidney transplant status with such biomarkers measuring instead of using invasive methods
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062528620N1
Registration date:2017-01-20, 1395/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
saeedeh jamali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 3009
Email address
sjamali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Molecular Immunology Research Center, Behestan Drug Administration, Tehran University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare changes two subsets of regulatory T cells (Treg) and gene expression of Foxp3, RORγT, T-bet and GATA-3 in kidney transplant patients under two different treatment protocols
Public title
The effect of two different drug protocols on the kidney transplant patients immune system
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1.Patients who receive a transplant for the first time; 2.live or unrelated cadavric donor (under 50 years); 3.All transplant recipients in terms of PRA (Panel reactive antibody) are negative; 4. Patients anti HLA antibody should be negative; 5. BMI <30; 6.Transplant recipients age: 65-18 years old; 7. The possibility of underlying diseases and infections in patients is low.
Exclusion criteria: 1. If the patient does not want to cooperate in the study; 2. Patients suffering from the nephrotoxicity.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz blvd.
City
Tehran
Postal code
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR.TUMS.VCR.1395.117
2
Ethics committee
Name of ethics committee
Added at 2017-03-05: Tehran University of Medical Sciences
Street address
Added at 2017-03-05:Tehran Province, Tehran, District 6, Pour Sina st
City
Added at 2017-03-05: Tehran
Postal code
بروزرسانی 1395/12/15
Approval date
empty
Ethics committee reference number
Added at 2017-03-05: IR.TUMS.REC.1395.2827
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
Regulatory T CD4+CD25+Foxp3+ cell
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Flow cytometry technique
2
Description
Regulatory T CD8+CD28- cell
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Flow cytometry technique
3
Description
Added at 2017-03-05: type 1 myeloid dendritic cells
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: Flow cytometry technique
4
Description
Added at 2017-03-05: plasmacytoid dendritic cells
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: Flow cytometry technique
5
Description
Added at 2017-03-05: T helper 17 cells
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: Flow cytometry technique
6
Description
Added at 2017-03-05: T helper 1 cells
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: Flow cytometry technique
7
Description
Added at 2017-03-05: T helper2 cells
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: Flow cytometry technique
Secondary outcomes
1
Description
Foxp3 gene
Timepoint
Before intervention and 4 months after intervention
Method of measurement
RT-PCR Technique
2
Description
T-bet gene
Timepoint
Before intervention and 4 months after intervention
Method of measurement
RT-PCR Technique
3
Description
RORγT gene
Timepoint
Before intervention and 4 months after intervention
Method of measurement
RT-PCR Technique
4
Description
GATA3 gene
Timepoint
Before intervention and 4 months after intervention
Method of measurement
RT-PCR Technique
5
Description
Added at 2017-03-05: Interferon gamma (IFNγ)
Timepoint
Added at 2017-03-05: Before intervention and 4 months after intervention
Method of measurement
Added at 2017-03-05: elisa technique
6
Description
Added at 2017-03-05: Interleukin-4
Timepoint
Added at 2017-03-05: Before intervention and 4 months after intervention
Method of measurement
Added at 2017-03-05: elisa technique
7
Description
Added at 2017-03-05: Interleukin-17A (IL-17A)
Timepoint
Added at 2017-03-05: Before intervention and 4 months after intervention
Method of measurement
Added at 2017-03-05: elisa technique
8
Description
Added at 2017-03-05: ILT4 gene
Timepoint
Added at 2017-03-05: Before intervention and 4 months after
Method of measurement
Added at 2017-03-05: RT-PCR Technique
9
Description
Added at 2017-03-05: ILT3 gene
Timepoint
Added at 2017-03-05: Before intervention and 4 months after intervention
Method of measurement
Added at 2017-03-05: RT-PCR Technique
10
Description
Added at: type 2 myeloid dendritic cells
Timepoint
Added at: Before intervention and 4 months after
Method of measurement
Added at: Flow cytometry technique
Intervention groups
1
Description
Group A:patients take tacrolimus with Mycophenolic acid.give them 0.1 mg / kg Tacrolimus for 90 days to achieve 8-12 ng/ml plasma levels. then for achieveing 5-8ng/ml plasma level will adjust the dose.Mycophenolate Mofetil (500 mg in 3 divided doses for 7 days and then the dose of 1000 mg or equivalent) will increase.
Category
Treatment - Drugs
2
Description
Group B: pateints take tacrolimus with sirolimus. give them 0.8 mg/kg tacrolimus for 6 months to achieve6-7 ng/ml plasma levels and then4-5 ng/ml the plasma level will adjust the dose in the next 6 months. 2 mg of Sirolimus per 48 hours of surgery and then 1 mg per day to achieve3-5 ng/ml plasma levels in the first 6 months and then the dose to achieve 6-8 ng/ml plasma levels will increase .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinezhad Hospital
Full name of responsible person
Dr. Pedram Ahmadpoor
Street address
Labbafinezhad Hospital, 9th Boostan, Pasdaran St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Molecular Immunology Research Center
Full name of responsible person
Dr. Aliakbar Amirzargar
Street address
Molecular Immunology Research Center, Children's Medical Center, Keshavarz Blvd.
City
Tehran
Grant name
457 /12د95
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Molecular Immunology 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
Behestan Pharmaceutical Company
Full name of responsible person
Dr.Younes Moradi
Street address
Behestan Pharmaceutical Company, Pardis St., Molla Sadra St., Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behestan Pharmaceutical Company
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
3
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Miss. Ahadi
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Jamali
Position
Master of Medical Immunology
Other areas of specialty/work
Street address
Children's Medical Center, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8895 3009
Fax
Email
jamali.sa71@gmail.com; sjamali@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Amirzargar
Position
Professor
Other areas of specialty/work
Street address
Children's Medical Center, Keshavarz Blvd.
City
Tehran
Postal code
141556446
Phone
+98 21 8895 3009
Fax
+98 21 8895 3009
Email
Amirzara@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Jamali
Position
Master of Medical Immunology
Other areas of specialty/work
Street address
Children's Medical Center, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8895 3009
Fax
Email
jamali.sa71@gmail.com; sjamali@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)