NCT00498342

Brief Summary

Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine. Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable

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

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 18, 2008

Status Verified

July 1, 2007

Enrollment Period

7 months

First QC Date

July 6, 2007

Last Update Submit

February 11, 2008

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine

    48 hours

Secondary Outcomes (1)

  • Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C

    48 hours

Interventions

N-acetylcysteineDRUG

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation
  • Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial

You may not qualify if:

  • Unable to give informed consent
  • Unwillingness to return for follow-up blood sampling
  • Unstable renal function
  • Subjects taking H2-blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont /Fletcher Allen Health Care, Inc.

Burlington, Vermont, 05401, United States

Location

Related Publications (5)

  • Solomon R. Contrast media nephropathy--how to diagnose and how to prevent? Nephrol Dial Transplant. 2007 Jul;22(7):1812-5. doi: 10.1093/ndt/gfm207. Epub 2007 Apr 20. No abstract available.

    PMID: 17449491BACKGROUND

  • Solomon RJ, Natarajan MK, Doucet S, Sharma SK, Staniloae CS, Katholi RE, Gelormini JL, Labinaz M, Moreyra AE; Investigators of the CARE Study. Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease. Circulation. 2007 Jun 26;115(25):3189-96. doi: 10.1161/CIRCULATIONAHA.106.671644. Epub 2007 Jun 11.

    PMID: 17562951BACKGROUND

  • Solomon R, Deray G; Consensus Panel for CIN. How to prevent contrast-induced nephropathy and manage risk patients: practical recommendations. Kidney Int Suppl. 2006 Apr;(100):S51-3. doi: 10.1038/sj.ki.5000375. No abstract available.

    PMID: 16612402BACKGROUND

  • Solomon R, Barrett B. Follow-up of patients with contrast-induced nephropathy. Kidney Int Suppl. 2006 Apr;(100):S46-50. doi: 10.1038/sj.ki.5000374.

    PMID: 16612401BACKGROUND

  • Solomon R, Briguori C, Bettmann M. Selection of contrast media. Kidney Int Suppl. 2006 Apr;(100):S39-45. doi: 10.1038/sj.ki.5000373.

    PMID: 16612400BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Richard J Solomon, M.D.

    University of Vermont/Fletcher Allen Health Care,Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 10, 2007

Study Start

June 1, 2007

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

February 18, 2008

Record last verified: 2007-07

Locations

US(1)