Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
NACTX
3 other identifiers
interventional
74
1 country
1
Brief Summary
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2005
Longer than P75 for not_applicable
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, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 14, 2009
October 1, 2009
3.2 years
October 9, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxidative stress: measure of the oxidative stress generated after the deceased renal transplant by laboratorial serum measure of Thiobarbituric Acid Reactive Substances (TBARS) with the Trichloroacetic acid method.
7 days
Secondary Outcomes (3)
Graft function: measure of serum creatinine
3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
3 months
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
3 months
Study Arms (2)
N-acetylcysteine
ACTIVE COMPARATORN-acetylcysteine 600 mg bid po 0-7 PO
control
SHAM COMPARATORNo treatment: standard care provided. No N-acetylcysteine administration.
Interventions
No treatment: standard care provided. No N-acetylcysteine administration.
Eligibility Criteria
You may qualify if:
- primary deceased renal transplant recipients
- adult (\>18 yo)
You may not qualify if:
- unable to drink N-acetylcysteine during the first 7 PO
- participation in other study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo General Hospital Kidney Transplant Unit
São Paulo, São Paulo, Brazil
Related Publications (1)
Danilovic A, Lucon AM, Seguro AC, Shimizu MHM, Ianhez LE, Nahas WC, Srougi M. N-acetylcysteine attenuates oxidative stress in deceased renal transplantation. The Journal of Urology 181 (4): 740; 2009.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Danilovic, MD
University of Sao Paulo General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 14, 2009
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
December 1, 2009
Last Updated
October 14, 2009
Record last verified: 2009-10