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A study of sotatercept given by injection for evaluating the safety, pharmacokinetics (effect of body on drug), and effect on anemia and bone disorder in people with end stage kidney disease on hemo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-003788-23

A study of sotatercept given by injection for evaluating the safety, pharmacokinetics (effect of body on drug), and effect on anemia and bone disorder in people with end stage kidney disease on hemodialysis that are switched from erythropoiesis stimulating agents (medication to treat anemia) to sotatercept

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Extrait

Part 1 To determine the multiple dose pharmacokinetics, safety, and tolerability of IV and SQ dosing of sotatercept administered at each dose level. Part 2 To determine the safety and efficacy of the selected starting dose(s), route(s) of administration, and dose modification regimen(s) on maintenance of hemoglobin concentrations between baseline and the Evaluation Phase

Critère d'inclusion

  • End-stage kidney disease (ESKD) who are on hemodialysis and will be switched from their current stable treatment with erythropoiesisstimulating agent (ESA) to sotatercept

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