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Impact of N-Acetylcysteine on Oxidative Stress and Renal Function in Deceased Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851708
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : March 2, 2009
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Brief Summary:
The aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant N-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.

Condition or disease Intervention/treatment Phase
Deceased Kidney Transplantation Drug: N-acetylcysteine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Oxidative Stress and Postoperatory Renal Function in Deceased Kidney Transplantation

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: NAC
Drug: N-acetylcysteine
600 mg bid orally from day 1 to 7 postoperative

No Intervention: control

Primary Outcome Measures :
  1. Tiobarbituric acid reactive species measures [ Time Frame: First seven postoperative days ]

Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: 7, 15, 30, 60, 90 postoperative day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • First transplant
  • Deceased kidney transplant

Exclusion Criteria:

  • postoperative recovery at critical care unit
  • illicit drug addiction
  • psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851708

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Clinics Hospital, University of Sao Paulo, Medical School
São Paulo, Brazil, 05403-001
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

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Responsible Party: Antonio Marmo Lucon, University of São Paulo Identifier: NCT00851708     History of Changes
Other Study ID Numbers: NAC vs DKT
FAPESP 06/52046-0
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: March 2, 2009
Last Verified: February 2009
Keywords provided by University of Sao Paulo:
deceased kidney transplant
oxidative stress
renal function measurements
Additional relevant MeSH terms:
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Pathologic Processes
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs