N-acetyl-cysteine (NAC) and Kidney Graft Function

Chronic Renal Insufficiency Clinical Trial

Official title:

Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998972
• Other study ID #: NAC-CHUN1
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2009
• Last updated: July 9, 2011
• Start date: September 2006
• Est. completion date: June 2011

Study information

• Verified date: June 2009
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in organ donors on the kidney graft function of recipients.

Description:

Ischemia-reperfusion is a major contributing factor for delayed renal function after transplantation. It has been shown that the administration of an antioxidant, i.e. NAC, in patients with chronic renal insufficiency may prevent radio contrast-induced nephropathy. Due to its antioxidant effects, organ donor pretreatment with NAC has demonstrated to improve renal graft function in two experimental studies. Study objectives: to compare the incidence of delayed graft renal function between two groups of patients, i.e., those receiving the graft from organ donors pretreated with NAC and a group control. The primary endpoint was the number of delayed graft function defined as the requirement of at least one sequence of dialysis during the first seven days following transplantation. Secondary endpoints: evolution of creatininemia, azotemia at day 1, 7, 14 and ,30 after surgery; acute and delayed transplant rejection; intrahospital mortality.

Patients inclusion: all organ donors and recipients were eligible Exclusion criteria: for organ donors were preexistent chronic renal insufficiency and contra-indications for kidney procurement; for recipient were transplantation outside our hospital The donors were randomized in a single-blind fashion into two groups : the control group and the group receiving 600 mg IV of NAC 1 hour before and 600 mg IV 2 hours after cerebral arteriography required to diagnose brain death. Sample size has been calculated delayed graft function by 50% leading to include 118 recipients in each group.

Follow up: one year after transplantation. Study beginning in september 2006. Length of inclusion during 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• all recipient for kidney graft in our hospital

Exclusion Criteria:

• transplantation out side our hospital

• refusal from the patient

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Death
• Chronic Renal Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography

Locations

Country	Name	City	State
France	CHU de Nice	NICE cedex 01	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delayed graft function		1 year	Yes
Secondary	Evolution of creatininemia and azotemia during the first month after transplantation		30 days	Yes
Secondary	Intrahospital mortality		30 days	Yes
Secondary	Acute and delayed graft rejection		30 days	Yes