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NCT00335101 Clinical Trial

Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00335101
Other study ID # GE-012-091
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date June 2006

Study information
Verified date April 2019
Source GE Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iodixanol, Ioversol, Iopromide

Locations
Country Name City State
Germany GE Healthcare Munich
United States GE Healthcare Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
GE Healthcare

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary endpoint:
Primary Maximum peak increase in SCr from baseline up to day 3.
Primary Secondary endpoints:
Primary Change in SCr from baseline to day 2 and to day 3
Primary Number of subjects with contrast-induced nephropathy (CIN)
Primary Quality of diagnostic information
Secondary Coronary Artery Disease (CAD)
Secondary Renal Impairment
Secondary Diabetes mellitus
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