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Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant (NACTX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00994305
First received: October 9, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.


Condition Intervention
Renal Transplantation
 Drug: N-acetylcysteine
Drug: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft function: measure of serum creatinine [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Graft function:estimated creatinine clearance by Cokcroft-Gault formula [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: April 2005
Estimated Study Completion Date: December 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-acetylcysteine
N-acetylcysteine 600 mg bid po 0-7 PO
 Drug: N-acetylcysteine
600 mg bid po 0-7 PO
Other Name: Fluimucil
Sham Comparator: control
No treatment: standard care provided. No N-acetylcysteine administration.
 Drug: control
No treatment: standard care provided. No N-acetylcysteine administration.
Other Name: N/A (not applicable)

Detailed Description:

Investigate the therapeutic effects of 600 mg bid po of N-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function.

Adult primary graft recipients of deceased renal donors will be randomly assign to treatment (NAC) or control group and prospectively evaluated for 90 days. Treatment group will receive N-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (PO). Renal function will be determined by serum creatinine, Cockroft-Gault estimated GFR (eGFR) at 7th, 15th, 30th, 60th and 90th PO and dialysis free Kaplan-Meier estimate curve. Serum levels of thiobarbituric acid reactive substances (TBARS), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th PO. Statistical analysis will be performed using SPSS 16.0.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary deceased renal transplant recipients
  • adult (>18 yo)

Exclusion Criteria:

  • unable to drink N-acetylcysteine during the first 7 PO
  • participation in other study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994305

Locations
Brazil
University of Sao Paulo General Hospital Kidney Transplant Unit
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Alexandre Danilovic, MD University of Sao Paulo General Hospital
  More Information

Publications:
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.

Responsible Party: ANTONIO MARMO LUCON, University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT00994305     History of Changes
Other Study ID Numbers: NACTX, FAPESP 06/52046-0, CAPPesq 076/05
Study First Received: October 9, 2009
Last Updated: October 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
kidney transplantation
oxidative stress
acetylcysteine
graft rejection

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 June 17, 2013