drugset / Trial / NCT01875523

PK of Serelaxin in Severe Renal Impairment and ESRD

NCT01875523

Phase 1 Completed 36 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.

Timeline

Start
2013-08
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Serelaxin Protein / enzyme biologic Intravenous