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

Renal Transplantation Clinical Trial

— NACTX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00994305
• Other study ID #: NACTX
• Secondary ID: FAPESP 06/52046-
• Status: Active, not recruiting
• Phase: N/A
• First received: October 9, 2009
• Last updated: October 13, 2009
• Start date: April 2005
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: December 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• N-acetylcysteine
600 mg bid po 0-7 PO
• control
No treatment: standard care provided. No N-acetylcysteine administration.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital Kidney Transplant Unit	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Graft function: measure of serum creatinine		3 months	No
Secondary	Graft function:estimated creatinine clearance by Cokcroft-Gault formula		3 months	No
Secondary	Graft function: dialysis free status by Kaplan-Meier actuarial curve of recipients free from dialysis after deceased renal transplant		3 months	No