In the present trial kidney-specific proteins were studied enzymatically or quantitatively in patients' urine after intravascular administration of water-soluble X-ray contrast media, in order to judge about their renal tolerance. 5 clinical trials (phase III), including 198 patients, were carried through, within several radiological examinations. The examined X-ray substance was Iosimide, a new monomeric, nonionic low osmolar c.m. It was compared to the nonionic Iopromide and Iopamidol as well as to the ionic, high osmolar sodium-meglumine-diatrizoate. Enzyme activities of alanine-aminopeptidase (AAP), gamma-glutamyltransferase (GGT), beta-n-acetylglucosaminidase (NAG), kallikrein with creatinine as point of reference were kinetically measured in 4 urine samples (1 before c.m. administration the others as 24 hours urine samples of the following 3 days). Beside the quantitative determination of protein and albumin an electrophoresis was started, when diagnosis was obvious. Kallikrein was brought to the diagnostic palette of this study in order to include the distal segment of the nephron. The specific protein excretion patterns of nonionic c.m. in urine are not different from each other. In contradiction to this, the results of the low osmolar nonionic Iosimide compared to the high osmolar diatrizoate, show evident differences for the benefit of Iosimide.

01 Jul 1990·Arzneimittel-Forschung

Effect of three non-ionic contrast media on rats and rabbits with regard to renal changes. Interspecies comparison.

Article

Author: Schöbel, C ; Günzel, P ; Hofmeister, R ; Siegmund, F ; Bhargava, A S

The effect of three non-ionic contrast media (iosimide, iopamidol and iopromide) was investigated in rabbits and rats after single i.v. application up to high doses with regard to renal changes. Determinations of serum urea nitrogen and creatinine and urinary enzymes (lactate dehydrogenase, gamma-glutamyl-transpeptidase and N-acetyl-beta-D-glucosaminidase) as well as histological examinations of the kidneys were performed. The results obtained demonstrate that rabbit as an experimental animal was more sensitive than rat in exhibiting renal changes to contrast media. Furthermore, determinations of urinary enzymes demonstrated that gamma-GT in rabbits and LDH in rats were the most sensitive indicators for detection of early kidney damage. With regard to the high dose levels required, these kidney changes do not indicate any risk to humans at diagnostic dose levels.

01 Jan 1989·Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband

Controlled, double-blind study of iosimide, a new, nonionic, monomeric contrast medium, and ioxaglate in cerebral angiography.

Article

Author: Schwartz, A ; Aulich, A ; Mull, M ; Lenzner, A

Iosimide is a new synthetic, nonionic, monomeric contrast medium in which a new substance, triiodine-trimesine acid, is used. It has definite advantages compared with the basic substances used in the past, diaminobenzoic acid and monoaminoisophthalic acid. Due to the high stability, the possibility of the formation of toxicologically questionable, free nuclei amino compounds disappears. Only the slightest probability of a cross-reaction with present antibodies exists, because of the low frequency in the environment. On the basis of the hydrophilic structure of the side chains, there is only a slight chemotoxicity. In a controlled, double-blind study on 100 randomized patients iosimide was tested in cerebral angiography against ioxaglate. Ioxaglate is an ionic contrast medium, popular because of its low osmolality. In this study iosimide exhibited no differences in comparison with ioxaglate with respect to the contrast, the neurological status or the liver or renal tolerance. In examining cardiovascular tolerance there is only a slight tendency toward liver changes with iosimide. Examination of the general tolerance, however, shows a statistically significant lower incidence of sensation of heat and pain with iosimide than with ioxaglate.

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Diagnostic agents	NDA/BLA	-	Bayer AG	-

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