First-in-human Phase I studies of PRS-080#22, a hepcidin antagonist, in healthy volunteers and patients with chronic kidney disease undergoing hemodialysis.

In chronic kidney disease both renal insufficiency and chronic inflammation trigger elevated hepcidin levels, which impairs iron uptake, availability. and erythropoiesis. Here we report the two first-in-human phase 1 trials of PRS-080#22, a novel, rationally engineered Anticalin protein that targets and antagonizes hepcidin.

Intra-arterial and intravenous applications of Iosimenol 340 injection, a new non-ionic, dimeric, iso-osmolar radiographic contrast medium: phase 2 experience.

Background: Iosimenol 340 injection is a new, dimeric, iso-osmolar, iodinated contrast medium for X-ray angiography.

Purpose: To compare the safety and efficacy of iosimenol injection to iodixanol injection in two randomized, controlled phase 2 trials.

Material And Methods: One hundred and forty-four adult patients were enrolled in the two trials, one for evaluation during arteriography and the other for evaluation during computed tomography.

The pharmacokinetic profile, tolerability and safety of the iodinated, non-ionic, dimeric contrast medium Iosimenol 340 injection in healthy human subjects.

Background: Iosimenol 340 injection is a new isotonic iodinated contrast medium for X-ray angiography.

Purpose: To investigate the pharmacokinetics and biotransformation, tolerability, and safety of Iosimenol 340 in healthy human subjects.

Material And Methods: Twenty-four subjects were enrolled and randomized to receive either Iosimenol 340 (0.

MRI characteristics in focal hepatic disease before and after administration of MnDPDP: discriminant analysis as a diagnostic tool.

The aim of this study was to determine if different types of focal hepatic lesions can be differentiated by specific quantitative and qualitative imaging characteristics pre- and post-Mangafodipir trisodium (MnDPDP) administration using a computerized multivariable, discriminant analysis (DA). In a multicenter trial, 151 patients with focal liver disease were studied at 1.5 and 1.