Study of the Effect of N-acetyl Cysteine on the Renal Graft Function Biomarkers (IL18, NGAL)
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
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 27, 2011
January 1, 2011
1 year
July 25, 2011
July 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
dialysis
60 days after transplantation
Study Arms (2)
N-Acetyl Cysteine
ACTIVE COMPARATORN-Acetyl Cysteine: receive N-Acetyl Cysteine in addition to standard treatment
standard treatment
NO INTERVENTIONThis group is without N-Acetyl Cysteine : just receives standard treatment
Interventions
600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
Eligibility Criteria
You may qualify if:
- patient receiving transplantation from living donors
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nephrology, Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jamshid Salamzadeh, PhD
SBMU School of Pharmacy, Tehran, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 27, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
November 1, 2012
Last Updated
July 27, 2011
Record last verified: 2011-01