Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
Recruitment status was Recruiting
Disorder Related to Renal Transplantation
Drug: N-acetyl Cysteine
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase 3 Study of N-acetyl Cysteine as an Antioxidant and Glutathione Synthesis Inducer on Biomarkers of Delayed Renal Graft Function Including NGAL and IL-18|
- renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation [ Time Frame: 4 and 24 hrs after renal graft ] [ Designated as safety issue: No ]
- dialysis [ Time Frame: 60 days after transplantation ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine: receive N-Acetyl Cysteine in addition to standard treatment
Drug: N-acetyl Cysteine
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
No Intervention: standard treatment
This group is without N-Acetyl Cysteine : just receives standard treatment
Kidney transplantation is the best treatment for most patients with end stage renal failure, but limited numbers of suitable kidneys are available for transplantation. So preservation of graft is vital. This necessitates the studies and interventions to improve outcome of renal transplantation surgery.
Delayed Graft Function (DGF) or delay in performance of transplanted kidney means absence of acceptable function in the renal activity in postgrafting phase. DGF is a consequence of ischemic and reperfusion injuries (IRI), and oxygen free radicals have a main role in pathophysiology of DGF. In meta-analysis studies, it has been demonstrated that DGF has a correlation with long and short time graft survival. Despite great advances in the transplantation procedure, dysfunction prevalence has not decreased. Major causes of this problem are the lack of appropriate markers for early diagnosis of DGF and on the other hand lack of appropriate and effective interventions to controll DGF.
Studies have shown that N-Acetyl Cysteine (NAC) can induce GSH synthesis, scavenger of free radicals, and infusion of NAC had similar effects as glutathione.
This is a randomized clinical trial (RCT) on patients who have received kidney transplantation from living donors. Sixty transplanted patients will be randomized into 2 groups. The first group of patients will be treated with NAC 600mg 6 hr before transplantation and two doses of NAC 12 hours apart after transplantation in addition to standard treatment, and the second group will receive only standard antirejection treatment. For all patients entered the study, urinary concentrations of IL18 and NGAL will be measured in designated times. Risk factors of DGF will be compared in two groups and effectiveness of NAC in reducing DGF will be determined.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403506
|Contact: Jamshid Salamzadeh, PhDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences||Recruiting|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator: Jamshid Salamzadeh|
|Principal Investigator: Mohsen Nafar, MD|
|Study Director:||Jamshid Salamzadeh, PhD||SBMU School of Pharmacy, Tehran, Iran|