NCT00998972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 12, 2011

Status Verified

June 1, 2009

Enrollment Period

4.3 years

First QC Date

October 17, 2009

Last Update Submit

July 9, 2011

Conditions

Brain DeathChronic Renal Insufficiency

Keywords

kidney graft,delayed graft functionN-acetylcysteine

Outcome Measures

Primary Outcomes (1)

  • Incidence of delayed graft function

    1 year

Secondary Outcomes (3)

  • Evolution of creatininemia and azotemia during the first month after transplantation

    30 days

  • Intrahospital mortality

    30 days

  • Acute and delayed graft rejection

    30 days

Study Arms (2)

control

NO INTERVENTION

control arm without any specific intervention

N-acetylcysteine

EXPERIMENTAL

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

Drug: N-acetylcysteine

Interventions

N-acetylcysteineDRUG

600 mg intravenous before and 2 hours after cerebral arteriography

Also known as: n-acetylcysteine administration
N-acetylcysteine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all recipient for kidney graft in our hospital

You may not qualify if:

  • transplantation out side our hospital
  • refusal from the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

Related Publications (2)

  • 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.

    PMID: 37916745DERIVED

  • 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.

    PMID: 25250647DERIVED

MeSH Terms

Conditions

Brain DeathRenal Insufficiency, ChronicDelayed Graft Function

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Carole R Ichai, MD, PhD

    Service de Reanimation Medicochirurgical. CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2009

First Posted

October 21, 2009

Study Start

September 1, 2006

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

July 12, 2011

Record last verified: 2009-06

Locations

FR(1)