NCT01875523

PK of Serelaxin in Severe Renal Impairment and ESRD

A Single Dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Serelaxin in Patients With Severe Renal Impairment or End-Stage Renal Disease on Hemodialysis Compared to Matched Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Failure, Chronic
• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Serelaxin

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-06-12
• Last updated: 2020-12-21

Locations

1 site across 1 country: Germany