Comparison of the effectiveness of De novo immunosuppressive regimen of sirolimus plus tacrolimus versus tacrolimus plus Mycofenolic acid in renal transplant recipients
Comparison the efficacy of sirolimus use in combination with tacrolimus as a De novo immunosuppressive regimen with the regimen contains tacrolimus and mycophenolic acid in kidney transplant recipients
Design
A randomized controlled trial with parallel group design. Randomization will computer generated. Block randomization method will be used and each block was of 10 patients
Settings and conduct
kidney transplant recipients between years 2016 and 2017 in Shahid Labbafinejad Medical center will enrolle for the study.
Participants/Inclusion and exclusion criteria
Patients who received kidney transplant from cadaver or living unrelated donor (age of cadaveric donor < 50 years) that were negative for panel reactive antibody (cytotoxicity), pre-transplantation anti-HLA, will be recruited. All patient were 18 to 65 years of age and had body mass index (BMI) less than 30 kg/m2. Patients who received kidney transplant previously will not include.
Intervention groups
In test group, sirolimus, 2 mg as a loading dose followed by doses to reach the trough levels of 3-5 ng/mL as maintenance regimen in combination with tacrolimus, 0.08 mg/kg/day for trough levels of 6-7 ng/mL in first 6 months after transplantation will be administered. In control group, tacrolimus, 0.1 mg/kg/day to reach the trough level of 8-10 ng/ml; mycophenolate sodium, 1080 mg daily for 7 first day followed by 720 mg as maintenance regimen in first 6 months after transplant will be administered
Main outcome variables
Renal function, graft rejection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160412027346N6
Registration date:2019-04-30, 1398/02/10
Registration timing:retrospective
Last update:2019-04-30, 1398/02/10
Update count:0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2016-02-23, 1394/12/04
Actual recruitment end date
2017-12-25, 1396/10/04
Trial completion date
2017-12-30, 1396/10/09
Scientific title
Comparison of the effectiveness of De novo immunosuppressive regimen of sirolimus plus tacrolimus versus tacrolimus plus Mycofenolic acid in renal transplant recipients
Public title
Efficacy of two type of immunosuppressive regimen in rate of graft rejection in the kidney transplant recipients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who received kidney transplant from cadaver
Patients who received kidney transplant from unrelated living donor (age of cadaveric donor > 50 years)
Negative for panel reactive antibody
Negative for pre-transplantation anti-HLA
BMI less than 30 kg/m2
Age between 18 to 65 years
Exclusion criteria:
previously transplanted patients
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:
46
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence will computer generate and consist of series of group number (either 1 = A or 2 = B) for each consecutive patient. Block randomization method will use and each block will be consist of 10 patients. Each block includes 5 patients who will receive sirolimus plus tacrolimus and 5 patients who will receive tacrolimus plus mycophenolate.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
BioMed Central Ltd
Secondary trial Id
ISRCTN19991928
Registration date
2637-11-06, 2016/08/15
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran Province, Tehran, Velenjak, Arabi Ave
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
IR.SBMU.UNRC.1394.25
Health conditions studied
1
Description of health condition studied
Kidney transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Estimation of glomerular filtration rate
Timepoint
at baseline and months 3, 6 and 12
Method of measurement
based on Modification of Diet in Renal Disease (MDRD)
2
Description
Biopsy proven acute rejection
Timepoint
months 3 and 12
Method of measurement
based on biopsy and screening renal tissue
Secondary outcomes
1
Description
Incidence of borderline changes, subclinical acute cellular rejection and subclinical antibody mediated rejection
Timepoint
month 4
Method of measurement
measured by protocol biopsy
2
Description
Incidence of new-onset diabetes after transplantation
Timepoint
at 3, 6, 12 months
Method of measurement
measurement of blood glucose
3
Description
Incidence of donor specific anti-HLA antibodies
Timepoint
at 4 and 12 months
Method of measurement
measured using solid phase ELISA
4
Description
Incidence of hypertension
Timepoint
3, 6 and 12 months
Method of measurement
by using mercury sphygmomanometer
5
Description
Incidence of dyslipidemia
Timepoint
at months 3, 6 and 12
Method of measurement
total cholesterol, LDL-C, HDL-C and TG serum level
6
Description
Incidence of CMV viremia ( >2000 copies/ml) and CMV disease (fever, leukopenia or organ involvement with CMV DNAemia >2000 copies/ml)
Timepoint
every month for first 3 months and then every 3 months for 1 year
Method of measurement
measured using CMV viral load By PCR
7
Description
Incidence of BK viremia ( >10000 copy/ml blood) and BK associated nephropathy
Timepoint
every month for first 3 months then every 3 months
Method of measurement
measured using BK virus plasma PCR
Intervention groups
1
Description
Intervention group: Immunosuppressive medications will be administered with the following dosages for patients after enrollment: ATG 3 mg/kg divided in 3 to 4 doses daily. Methylprednisolone 250 mg daily for 2 days, followed by prednisolone 1 mg/kg (maximum of 60 mg) for 3 days afterward, then it will taper down by 5 mg daily to reach the dose of 15 mg on day 14, 10 mg daily on day 30 and finally 5 mg daily on day 60 and thereafter. afterward, SRL, 2 mg as a loading dose followed by doses to reach the trough levels of 3-5 ng/mL as maintenance regimen in combination with TAC, 0.08 mg/kg/day for trough levels of 6-7 ng/mL in first 6 months after transplantation will be administered
Category
Treatment - Drugs
2
Description
Control group: Immunosuppressive medications will be administered with the following dosages for patients after enrollment: ATG 3 mg/kg divided in 3 to 4 daily doses , Methylprednisolone 250 mg daily for 2 days, followed by prednisolone 1 mg/kg (maximum of 60 mg) for 3 days afterward, then prednisolone will be tapered by 5 mg daily to reach the dose of 15 mg on day 14, 10 mg daily on day 30 and finally 5 mg daily on day 60 and thereafter. Afterward, TAC, 0.1 mg/kg/day to reach the trough level of 8-12 ng/ml; Myfortic®, 1080 mg daily for 7 first day followed by 720 mg as maintenance regimen in first 6 months after transplant will be administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Medical center
Full name of responsible person
Dr Shadi Ziaie
Street address
9th Boostan Pasdaran St Tehran
City
Tehran
Province
Tehran
Postal code
5546859685
Phone
+98 21 23601
Email
Shadiziaie@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Street address
9th Boostan Pasdaran St
City
Tehran
Province
Tehran
Postal code
3366339956
Phone
+98 21 23601
Email
Shadiziaie@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 23602188021
Email
shadiziaie@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shadi Ziaie
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
9th Boostan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
2356987452
Phone
+98 23602188021
Email
shadiziaie@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omid moradi
Position
Clinical pharmacy resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
school of pharmacy, Niayesh crossroad, Vali-asr st.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
O_moradi@sbmu.ac.ir
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
at the end of the study all the data after blinding and statistical analysis based on what mentioned in methodology will be extracted and published online as a scientific paper
When the data will become available and for how long