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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998972
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : July 12, 2011
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

October 17, 2009
October 21, 2009
July 12, 2011
September 2006
December 2010   (Final data collection date for primary outcome measure)
Incidence of delayed graft function [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00998972 on Archive Site
  • Evolution of creatininemia and azotemia during the first month after transplantation [ Time Frame: 30 days ]
  • Intrahospital mortality [ Time Frame: 30 days ]
  • Acute and delayed graft rejection [ Time Frame: 30 days ]
Same as current
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N-acetyl-cysteine (NAC) and Kidney Graft Function
Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Brain Death
  • Chronic Renal Insufficiency
Drug: N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Other Name: n-acetylcysteine administration
  • No Intervention: control
    control arm without any specific intervention
  • Experimental: N-acetylcysteine
    administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death
    Intervention: Drug: N-acetylcysteine
Orban JC, Quintard H, Cassuto E, Jambou P, Samat-Long C, Ichai C. Effect of N-acetylcysteine pretreatment of deceased organ donors on renal allograft function: a randomized controlled trial. Transplantation. 2015 Apr;99(4):746-53. doi: 10.1097/TP.0000000000000395.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all recipient for kidney graft in our hospital

Exclusion Criteria:

  • transplantation out side our hospital
  • refusal from the patient
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Carole Ichai, Institut d'Anesthésiologie des AM
Institut d'Anesthesiologie des Alpes Maritimes
Not Provided
Principal Investigator: Carole R Ichai, MD, PhD Service de Reanimation Medicochirurgical. CHU de Nice
Institut d'Anesthesiologie des Alpes Maritimes
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP