Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Disorder Related to Renal Transplantation
Intervention: N-acetyl Cysteine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Shaheed Beheshti Medical University Official(s) and/or principal investigator(s):
Jamshid Salamzadeh, PhD, Study Director, Affiliation: SBMU School of Pharmacy, Tehran, Iran
Overall contact:
Jamshid Salamzadeh, PhD, Phone: 00982188662334, Email: j.salamzadeh@yahoo.com
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: renal function biomarkers (IL18, NGAL)difference between study and control group in 4 and 24 hr after transplantation
Secondary outcome: dialysis
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jamshid Salamzadeh, PhD, Phone: 00982188662334, Email: j.salamzadeh@yahoo.com
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Islamic Republic of; Recruiting
Jamshid Salamzadeh, Principal Investigator
Mohsen Nafar, MD, Principal Investigator
Additional Information
Starting date: April 2011
Last updated: July 26, 2011
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