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

Disorder Related to Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01403506
• Other study ID #: 186
• Status: Recruiting
• Phase: Phase 3
• First received: July 25, 2011
• Last updated: July 26, 2011
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2011
• Source: hahid Beheshti University of Medical Sciences
• Contact: Jamshid Salamzadeh, PhD
• Phone: 00982188662334
• Email: j.salamzadeh[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation

Intervention

Drug:
• N-acetyl Cysteine
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation		4 and 24 hrs after renal graft	No
Secondary	dialysis		60 days after transplantation	No