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

October 13, 2009 updated by: University of Sao Paulo General Hospital
Investigate the therapeutic effects of the antioxidant N-acetylcysteine on early outcomes of deceased renal transplant patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • University of Sao Paulo General Hospital Kidney Transplant Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: N-acetylcysteine
N-acetylcysteine 600 mg bid po 0-7 PO
Drug: N-acetylcysteine
600 mg bid po 0-7 PO
Other Names:
  • 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 Names:
  • N/A (not applicable)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Graft function: measure of serum creatinine
Time Frame: 3 months
3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
Time Frame: 3 months
3 months
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Alexandre Danilovic, MD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NACTX
  • FAPESP 06/52046-0
  • CAPPesq 076/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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