NCT00575419

Brief Summary

This will be a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a procedure or imaging that requires the administration of contrast media at Oregon Health \& Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes prior to the procedure or imaging requiring contrast media. Toxicity will be graded according to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is defined as an increase in serum creatinine concentration of 25% or more from the subjects baseline value within a 72-hour period after the administration of contrast media. Serum creatinine concentration will be measured at admission, every day during in-patient hospitalization, and at hospital discharge.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2014

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

6.9 years

First QC Date

December 14, 2007

Last Update Submit

July 31, 2019

Conditions

Contrast Induced Nephropathy

Keywords

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Toxicity will be graded according to NCI CTCAE version 3.0.

    2 years

Secondary Outcomes (3)

  • Baseline serum creatinine and calculated creatinine clearance to provide sample size estimates for future studies.

    2 years

  • To estimate the efficacy of NAC in reducing the incidence of CIN.

    2 years

  • To determine NAC pharmacology administered IV or IA.

    2 years

Study Arms (2)

1, IV NAC

EXPERIMENTAL

N-acetylcysteine administered intravenously

Drug: N-acetylcysteine

2, IA NAC

EXPERIMENTAL

N-acetylcysteine administered intra-arterial

Drug: N-acetylcysteine

Interventions

N-acetylcysteineDRUG

* Dose Level 1: 150 mg/kg/day * Dose Level 2: 300 mg/kg/day * Dose Level 3: 600 mg/kg/day * Dose Level 4: 900 mg/kg/day * Dose Level 5: 1200 mg/kg/day

1, IV NAC2, IA NAC

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal failure, stage 3 or worse
  • Undergoing endovascular procedure with an isotonic, non ionized contrast agent
  • Life expectancy at least 4 weeks from date of registration
  • Platelets greater than or equal to 100,000/mm3
  • Systolic pressure of greater than 90 mm Hg
  • No contraindications to N-Ac or contrast agent
  • Not at risk for general anesthesia

You may not qualify if:

  • Acute renal failure
  • Undergoing dialysis
  • Decompensate cardiac failure
  • Pregnant or nursing
  • History of clinically significant reactive airway disease
  • Receiving non-steroidal anti-inflammatory agent within 24 hours of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Stenstrom DA, Muldoon LL, Armijo-Medina H, Watnick S, Doolittle ND, Kaufman JA, Peterson DR, Bubalo J, Neuwelt EA. N-acetylcysteine use to prevent contrast medium-induced nephropathy: premature phase III trials. J Vasc Interv Radiol. 2008 Mar;19(3):309-18. doi: 10.1016/j.jvir.2007.11.003.

    PMID: 18295688RESULT

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Edward A Neuwelt, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

November 1, 2007

Primary Completion

September 15, 2014

Study Completion

September 15, 2014

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations

US(1)