Study of the changes in level of NGAL, biomarker of transplanted kidney function by application of N-acetyl cysteine in cadaveric renal transplant recipients
This study is undertaken to evaluate the effect of acetylcysteine administration on delayed graft function and early outcomes of kidney transplantation in cadaveric renal transplant recipients. Seventy adult recipients of a deceased-donor kidney transplant will be randomized into two groups. The first group of patients will be treated with 600 mg acetylcysteine, one dose before transplantation and from the first day after transplantation, every 12 hours up to fifth day, in addition to standard treatment. The second group will receive placebo one dose before transplantation and then twice daily up to fifth day. For all patients entered the study, urinary and plasma neutrophil gelatinase-associated lipocalin (NGAL) concentrations as an early marker of delayed graft function, will be measured in designated times. Risk factors for delayed graft function will be compared in two groups and effectiveness of acetylcysteine in reducing delayed graft function will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090214693N4
Registration date:2014-12-09, 1393/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-09, 1393/09/18
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center,Shahid Beheshti Medical University,School of Pharmacy
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the changes in level of NGAL, biomarker of transplanted kidney function by application of N-acetyl cysteine in cadaveric renal transplant recipients
Public title
Study of the effect of N-acetyl cysteine on biomarker of delayed graft function in cadaveric renal transplant recipients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: kidney transplant recepients from deceased-donor; over 18 years of age
exclusion criteria: Recent stroke; hyperoxaluria; Sensitivity to sulfonamides; PRA>30%; Second transplantation; Less then 2 cc urine volume before transplantation
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center
Street address
Pasdaran, Paidarfard avenue, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center
City
Tehran
Postal code
1666677951
Approval date
2014-03-13, 1392/12/22
Ethics committee reference number
20
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
urine and plasma NGAL
Timepoint
pre-transplantation, dar 1 and 5 after transplantation
Method of measurement
ELISA kit
Secondary outcomes
1
Description
need for dialysis in the firs week post transplantation or creatinine reduction ratio less than 10% per day in 3 consecutive days after transplantation
Timepoint
daily
Method of measurement
laboratory reports for SrCr and clinical sign and symptoms for dialysis
Intervention groups
1
Description
In control group placebo will administered one dose before transplantation and then twice per day from day one to five after transplantation
Category
Prevention
2
Description
In intervention group 600 mg acetylcysteine will administered one dose before transplantation and then twice per day from day one to five after transplantation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad Hospital
Full name of responsible person
Dr Mohsen Nafar
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University, School of Pharmacy and Shahid Labbafinejad Medical Center and Ur