WithdrawnPhase 4

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

Stopped: Sponsor Decision to withdraw study (comparative product withdrawn from the market)

United States, Germany0Started 2006-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT00335101

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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