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

NCT ID: NCT00998972

Last Updated: 2011-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Death Chronic Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

control arm without any specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

N-acetylcysteine

administration of 600 mg intravenous N-acetyl cysteine before and 2 hours after angiography performed for the diagnosis of brain death

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

600 mg intravenous before and 2 hours after cerebral arteriography

Interventions

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N-acetylcysteine

600 mg intravenous before and 2 hours after cerebral arteriography

Intervention Type DRUG

Other Intervention Names

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n-acetylcysteine administration

Eligibility Criteria

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Inclusion Criteria

* all recipient for kidney graft in our hospital

Exclusion Criteria

* transplantation out side our hospital
* refusal from the patient
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Anesthesiologie des Alpes Maritimes

OTHER

Sponsor Role lead

Responsible Party

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Institut d'Anesthésiologie des AM

Principal Investigators

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Carole R Ichai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Reanimation Medicochirurgical. CHU de Nice

Locations

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CHU de Nice

Nice, Alpes Maritimes, France

Site Status

Countries

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France

References

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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

Reference Type DERIVED
PMID: 37916745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25250647 (View on PubMed)

Other Identifiers

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NAC-CHUN1

Identifier Type: -

Identifier Source: org_study_id

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