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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994305

Acronym

NACTX

Enrollment

Registered

2009-10-14

Start date

2005-04-30

Completion date

2009-12-31

Last updated

2009-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

kidney transplantation, oxidative stress, acetylcysteine, graft rejection

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.

Interventions

DRUGN-acetylcysteine

600 mg bid po 0-7 PO

DRUGcontrol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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.	7 days

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026