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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403506
Recruitment Status : Unknown
Verified January 2011 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
Information provided by:
Shahid Beheshti University of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Drug: N-acetyl Cysteine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Other Names:
  • Acetylcysteine
  • ACC 600

No Intervention: standard treatment
This group is without N-Acetyl Cysteine : just receives standard treatment

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. dialysis [ Time Frame: 60 days after transplantation ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01403506

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Contact: Jamshid Salamzadeh, PhD 00982188662334

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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         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Study Director: Jamshid Salamzadeh, PhD SBMU School of Pharmacy, Tehran, Iran
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Responsible Party: Jamshid Salamzadeh/Dr, Shaheed Beheshti Medical University Identifier: NCT01403506    
Other Study ID Numbers: 186
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: January 2011
Keywords provided by Shahid Beheshti University of Medical Sciences:
kidney transplantation
N-Acetyl Cysteine
living donor
delayed graft function
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs