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

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ClinicalTrials.gov Identifier: NCT00998972
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Death Chronic Renal Insufficiency Drug: N-acetylcysteine Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function
Study Start Date : September 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: N-acetylcysteine
600 mg intravenous before and 2 hours after cerebral arteriography
Other Name: n-acetylcysteine administration




Primary Outcome Measures :
  1. Incidence of delayed graft function [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evolution of creatininemia and azotemia during the first month after transplantation [ Time Frame: 30 days ]
  2. Intrahospital mortality [ Time Frame: 30 days ]
  3. Acute and delayed graft rejection [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all recipient for kidney graft in our hospital

Exclusion Criteria:

  • transplantation out side our hospital
  • refusal from the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998972


Locations
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France
CHU de Nice
NICE cedex 01, Alpes Maritimes, France, 06000
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Investigators
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Principal Investigator: Carole R Ichai, MD, PhD Service de Reanimation Medicochirurgical. CHU de Nice

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carole Ichai, Institut d'Anesthésiologie des AM
ClinicalTrials.gov Identifier: NCT00998972     History of Changes
Other Study ID Numbers: NAC-CHUN1
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: June 2009
Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
kidney graft,
delayed graft function
N-acetylcysteine
Additional relevant MeSH terms:
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Brain Death
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes