NCT00335101

Brief Summary

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.

Trial Health

40
At Risk

Trial Health Score

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

Geographic Reach
2 countries

2 active sites

Status
withdrawn

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, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

First QC Date

June 6, 2006

Last Update Submit

April 25, 2019

Conditions

Coronary Artery Disease (CAD)Renal ImpairmentDiabetes Mellitus

Keywords

Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)

Outcome Measures

Primary Outcomes (6)

  • Primary endpoint:

  • Maximum peak increase in SCr from baseline up to day 3.

  • Secondary endpoints:

  • Change in SCr from baseline to day 2 and to day 3

  • Number of subjects with contrast-induced nephropathy (CIN)

  • Quality of diagnostic information

Secondary Outcomes (3)

  • Coronary Artery Disease (CAD)

  • Renal Impairment

  • Diabetes mellitus

Interventions

Iodixanol, Ioversol, IopromideDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

You may not qualify if:

  • Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl \< 20 mL/min will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

GE Healthcare

Munich, 80807, Germany

Location

MeSH Terms

Conditions

Coronary Artery DiseaseRenal InsufficiencyDiabetes Mellitus

Interventions

iodixanolioversoliopromide

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marc Pignot, PhD

    GE Healthcare

    STUDY DIRECTOR

  • Johnny Gibbs, Jr., CCRA

    GE Healthcare

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2006

First Posted

June 8, 2006

Study Start

June 1, 2006

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

US(1)DE(1)