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End-stage Renal Disease (ESRD) Pilot Study

NCT03787368 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-03-16

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.

Conditions

  • Renal Dialysis

Interventions

DRUG

BAY1213790

Single intravenous infusion of BAY1213790 (Two different doses)

DRUG

0.9% sodium chloride solution

Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2021-09-15
Completion
2021-09-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787368 on ClinicalTrials.gov