The purpose of this clinical trial is to investigate prophylactic effect of Mycophenolate Mofetil in delayed graft function and early outcome of living-kidney transplantation in ESRD patients. 88 end stage renal disease patoents who are candidates for living-donor renal transplantation in Emam Reza hospital of Kermanshah will be included in the study and cases with Second or more transplantation, cadaver transplantation will be excluded. The patients will be assigned into intervention group who receive Mycophenolate mofetil (1000 mg/bid) 5 day prior to live-donor kidney transplantation. Control group will receive no treatment. After transplantation, risk of delayed graft function and acute rejection will be evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901153623N1
Registration date:2010-05-05, 1389/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-05, 1389/02/15
Registrant information
Name
Mohsen Alemi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6309
Email address
malemi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology-Urology Reaserch Center of Kermanshah University of Medical Sciences
Expected recruitment start date
2009-03-10, 1387/12/20
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A servey of prophylactic effect of Mycophenolate Mofetil in delayed graft function and early outcome of living-kidney transplantation
Public title
A servey of prophylactic effect of Mycophenolate Mofetil in delayed graft function and early outcome of living-kidney transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of end stage renal diseases who are candidates for renal transplantation
Exclusion criteria: Second or more transplantation, cadaver transplantation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Ave.
City
Kermanshah
Postal code
Approval date
2010-01-16, 1388/10/26
Ethics committee reference number
2010/01/16
Health conditions studied
1
Description of health condition studied
End-stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Plasma Cratinin
Timepoint
Daily
Method of measurement
Blood sample
Secondary outcomes
1
Description
Rate of acute rejection
Timepoint
Daily
Method of measurement
Physical Examination
Intervention groups
1
Description
Tab mycophenolate mofetil 1000 mg/bid 5 days before transplantation and placebo
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology-Urology Reaserch Center of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahram Samadzadeh
Street address
Emam Reza Hospital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology-Urology Reaserch Center of Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahram Samadzadeh
Position
Urology / MD
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
bsamadzadeh@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nephrology-Urology Reaserch Center of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahram Samadzade
Position
Urology / MD
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
bsamadzadeh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohsen Alemi
Position
Urologic rezident
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)