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

Primary Purpose

Renal Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
N-acetylcysteine
control
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Transplantation focused on measuring kidney transplantation, oxidative stress, acetylcysteine, graft rejection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital Kidney Transplant Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

N-acetylcysteine

control

Arm Description

N-acetylcysteine 600 mg bid po 0-7 PO

No treatment: standard care provided. No N-acetylcysteine administration.

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2009
Last Updated
October 13, 2009
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00994305
Brief Title
Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Acronym
NACTX
Official Title
Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplantation
Keywords
kidney transplantation, oxidative stress, acetylcysteine, graft rejection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
N-acetylcysteine 600 mg bid po 0-7 PO
Arm Title
control
Arm Type
Sham Comparator
Arm Description
No treatment: standard care provided. No N-acetylcysteine administration.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
Fluimucil
Intervention Description
600 mg bid po 0-7 PO
Intervention Type
Drug
Intervention Name(s)
control
Other Intervention Name(s)
N/A (not applicable)
Intervention Description
No treatment: standard care provided. No N-acetylcysteine administration.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Graft function: measure of serum creatinine
Time Frame
3 months
Title
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
Time Frame
3 months
Title
Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Danilovic, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital Kidney Transplant Unit
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Learn more about this trial

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

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