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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01403506
First received: July 25, 2011
Last updated: July 26, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Disorder Related to Renal Transplantation
Drug: N-acetyl Cysteine
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • dialysis [ Time Frame: 60 days after transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403506

Contacts
Contact: Jamshid Salamzadeh, PhD 00982188662334 j.salamzadeh@yahoo.com

Locations
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 Medical University
Investigators
Study Director: Jamshid Salamzadeh, PhD SBMU School of Pharmacy, Tehran, Iran
  More Information

No publications provided

Responsible Party: Jamshid Salamzadeh/Dr, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01403506     History of Changes
Other Study ID Numbers: 186
Study First Received: July 25, 2011
Last Updated: July 26, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
kidney transplantation
N-Acetyl Cysteine
living donor
delayed graft function

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 22, 2014