Comparison of two different drug regimen containing tacrolimus and cyclosporine on graft survival and the survival rate of patients as immunosuppressive regimens in kidney transplantation
This study compare the effect of two drug regimen containing tacrolimus and cyclosporine on graft survival and the survival rate of patients as immunosuppressive regimens in kidney transplantation, in the center of Imam Reza (AS), Kermanshah, Iran. We will recruit 100 patients in each group. Inclusion criteria: all patients with chronic renal failure aged 16 to 65 who were undergoing kidney transplantation and immunosuppressive therapy for graft. Exclusion criteria: patients with other diseases such as cancer; intraoperative surgical complications in renal transplantation in grafts; graft loss due to vascular complications created from the graft surgery; death (due to other causes than rejection); switching immunosuppressive treatment regimen for any reason. Patients will be divided into two groups under two drug regimens: The first diet includes tacrolimus + micofenolate meftile «Cellcept» + prednisolone and second regime includes cyclosporine + micofenolate meftile «Cellcept» + prednisone. For one year, both groups will be under the detailed follow up and review of acute rejection, chronic rejection, measurement of plasma creatinine levels and creatinine clearance rate, graft and patient survival factors. Patients in the months of third, sixth, ninth and twelfth after transplantation will be visited and variables will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105166500N1
Registration date:2011-06-19, 1390/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Abdoreza Mahrui
Name of organization / entity
Kermanshah University of Medical Scienes and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6301
Email address
abmahrooei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical scinces
Expected recruitment start date
2011-05-03, 1390/02/13
Expected recruitment end date
2013-01-02, 1391/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two different drug regimen containing tacrolimus and cyclosporine on graft survival and the survival rate of patients as immunosuppressive regimens in kidney transplantation
Public title
Comparison of cyclosporine and tacrolimus in two immunosuppressive drug regimen in patients undergoing kidney transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients with chronic renal failure aged 16 to 65 who were undergoing kidney transplantation and immunosuppressive therapy for graft. Exclusion criteria: patients with other diseases such as cancer; intraoperative surgical complications in renal transplantation in grafts; graft loss due to vascular complications created from the graft surgery; death (due to other causes than rejection); switching immunosuppressive treatment regimen for any reason.
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical scinces
Street address
building no 2 of Kermenshah university of medical scinces, Shahid Beheshti Blvrd
City
Kermanshah
Postal code
Approval date
2011-05-03, 1390/02/13
Ethics committee reference number
420
Health conditions studied
1
Description of health condition studied
survival of transplanted kidney
ICD-10 code
T86.1
ICD-10 code description
Kidney transplant failure and rejection
Primary outcomes
1
Description
acute rejection of kidney transplantation
Timepoint
1 , 3 , 6 , 9 , 12 months after transplantation
Method of measurement
clinical findings, sonographic findings, findings of DTPA scan, biopsy
2
Description
coronic rejection of kidney transplantation
Timepoint
1 , 3 , 6 , 9 , 12 months after transplantation
Method of measurement
Gradual increase in plasma creatinine and the need for dialysis in patient that has not required dialysis. based on clinical symptoms, renal biopsy diagnosed increase of creatinine gradually.
Secondary outcomes
1
Description
GFR
Timepoint
1 , 3 , 6 , 9 , 12 months after transplantation
Method of measurement
with GFR formula
2
Description
drugs side effect
Timepoint
1 , 3 , 6 , 9 , 12 months after transplantation
Method of measurement
alergy, intolerance, blood presure increase
Intervention groups
1
Description
Group B: tacrolimus: 1 mg twice a day immediately after transplantation until a year. Micofenolate meftile: the night before the transplant, 1 g, twice a day until a year. Prednisolone:at first, 3 pulse methylprednisolone for 3 days after transplantation is given, then 1 mg/kg/day gradually to 2 / 0 mg/kg/day and reduction is given in one year to 10 mg/day.
Category
Treatment - Drugs
2
Description
Group A: Cyclosporine: after transplantation, 12 mg/kg/day, gradually reduced to half the dose in the first month and then a dose of 5 mgr/kg/day, until one year. Micofenolate meftile: the night before the transplant, 1 g, twice a day until a year. Prednisolone: at first, 3 pulse methylprednisolone for 3 days after transplantation is given, then 1 mg/kg/day gradually to 2 / 0 mg/kg/day and reduction is given in one year to 10 mg/day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Scienes and Health Services
Full name of responsible person
Dr. Farid Najafi
Street address
Bulding No2 of Kermanshah University of Medical Scienes and Health Services, Shahid Beheshti Blvrd.
City
Kermanshah
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 Scienes and Health Services
Proportion provided by this source
100
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
Kermanshah University of Medical Scienes and Health Services
Full name of responsible person
Dr. Abdoreza Mahrui
Position
Resident of internal medicine
Other areas of specialty/work
Street address
Internal medicine Department of Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6301
Fax
Email
abmahrooei@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Scienes and Health Services
Full name of responsible person
D. Dariush Daisi
Position
Specialist in Nephrology
Other areas of specialty/work
Street address
Internal medicine Department of Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6301
Fax
+98 83 1427 6477
Email
abmahrooei@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)