Overview

This trial is active, not recruiting.

Condition renal transplantation
Treatments n-acetylcysteine, control
Sponsor University of Sao Paulo General Hospital
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date April 2005
End date June 2008
Trial size 74 participants
Trial identifier NCT00994305, CAPPesq 076/05, FAPESP 06/52046-0, NACTX

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
N-acetylcysteine 600 mg bid po 0-7 PO
n-acetylcysteine Fluimucil
600 mg bid po 0-7 PO
(Sham Comparator)
No treatment: standard care provided. No N-acetylcysteine administration.
control N/A (not applicable)
No treatment: standard care provided. No N-acetylcysteine administration.

Primary Outcomes

Measure
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 Outcomes

Measure
Graft function: measure of serum creatinine
time frame: 3 months
Graft function:estimated creatinine clearance by Cokcroft-Gault formula
time frame: 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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Protective Effect of N-acetylcysteine on Early Outcomes of Deceased Renal Transplant
Principal investigator Alexandre Danilovic, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.