The study was desighned as a prospective,randomized trial to assess the safety and efficacy of thymoglobulin in renal transplantation.This study will be included 106 patients who will be transplanted in Golestan hospital.The patients who have full-matched Human Leukocyte Antigens with donor,have containdication for thymoglobulin or have active transpalted organ other than the kidney,will be excluded from the study.The patients will be randomly divided into two groups.53 patients will be assigned to the control group and 53 patients will be assigned into thymoglobulin group. Standard immunosuppressive therapy is identical in both groups and consisted of corticosteroid, mycophenolate mofetil and cyclosporine or tacrolimus.second group will recived thymoglobulin , in addition to the standard immunosuppressive therapy. The patients will be followed for one year and the rate of transplanted kidney rejection, function of transplanted kidney and side effect of medications will be evaluated in both group and be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050933884N1
Registration date:2017-06-03, 1396/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Leila Sabetnia
Name of organization / entity
Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3441 2263
Email address
sabetnia-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical outcome of induction immunosuppressive therapy with thymoglobuline and standard therapy in kidney transplantation
Public title
Comparison the rate of acue transplant rejection and side effect of therapy with and without thymoglobuline in kidney transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : all the patients who are tranplanted in golestan hospital
Exclusion criteria : donor and recipient full-matched HLA; contraindication for administration of thymoglobulin; peresence of organ transplantation other than the kidney
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
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
Ahwaz University of Medical Sciences
Street address
Farvadin st, Golestan distcrit
City
Ahwaz
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.AJUMS.REC.1394.329
Health conditions studied
1
Description of health condition studied
Kidney Transplantation status
ICD-10 code
Z94.0
ICD-10 code description
kidney transplant status
Primary outcomes
1
Description
Glomrular Filtration Rate
Timepoint
Monthly
Method of measurement
cc per minute,MDRD equation
Secondary outcomes
1
Description
Side Effects of Medications
Timepoint
Monthly
Method of measurement
Questionnarire and Lab data
Intervention groups
1
Description
standard therapy and Induction therapy with Thymoglobulin
Category
Treatment - Drugs
2
Description
Standard therapy without thymoglobulin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Golestan Hospital
Full name of responsible person
Sabetnia Leila
Street address
Golestan Hospital, Golestan Distcrit
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Shahbazian Heshmatollah MD
Street address
Farvardin st, Golestan distcrit
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapour University of Medical Sciences
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
Golestan Hospital
Full name of responsible person
Sabetnia Leila
Position
Specialist/ Subspecialist assistant
Other areas of specialty/work
Street address
Farvardin st, Golestan distcrit
City
Ahwaz
Postal code
Phone
+98 61 3441 2263
Fax
Email
sabetnia-l@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapour University of medical sciences
Full name of responsible person
Shahbazian Heshmatollah
Position
Professor/Subspecialist
Other areas of specialty/work
Street address
No 163, West 6 st, Kyanpars
City
Ahwaz
Postal code
Phone
+98 61 3374 3013
Fax
Email
shahbazian_he@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Sabetnia Leila
Position
Specialist/Subspecialist assistant
Other areas of specialty/work
Street address
No47, Boulvar St, Mellat distcrit
City
Ahwaz
Postal code
Phone
+98 61 3441 2263
Fax
Email
leila.sabetnia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)