Clinical trial NCT01403506: Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Disorder Related to Renal Transplantation
Keywords: kidney transplantation
N-Acetyl Cysteine
living donor
delayed graft function
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patient receiving transplantation from living donors

Exclusion Criteria:

* having a neoplastic disease
* brain tumor
* having inflammatory diseases in their active phase (SLE)
* an acute infection, meningitis, sepsis
* Sickle Cell Disease
* Pregnancy
* Cardio-renal syndrome
* endogenous Cushing's syndrome
* chronic use of cimetidine
* a history of acute pancreatitis in recent months
* Multiple Sclerosis
* cardiac bypass in a recent month
* cirrhosis due to Hepatitis C
* having Alzheimer's disease
* having a untreated major depressive illness or schizophrenia
* Stroke in recent months
* Hyperoxaluria
* sensitivity to sulfonamides

Primary outcomes:
measure: renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation
timeFrame: 4 and 24 hrs after renal graft
Secondary outcomes:
measure: dialysis
timeFrame: 60 days after transplantation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Study officials:
affiliation: SBMU School of Pharmacy, Tehran, Iran
name: Jamshid Salamzadeh, PhD
role: STUDY_DIRECTOR
References: