NCT01403506

Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of (NAC) N-Acetyl Cysteine on biomarkers of Delayed Graft Function (DGF), including Neutrophil Gelatinase Associated Lipocalin (NGAL) and Intereleukin 18 (IL18).

Detailed description

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.

Conditions

• Disorder Related to Renal Transplantation

Interventions

Type	Name	Description
DRUG	N-acetyl Cysteine	600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-04-01
• Completion: 2012-11-01
• First posted: 2011-07-27
• Last updated: 2011-07-27

Locations

1 site across 1 country: Iran