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B1 Receptor Blocker

BAY2395840 for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose up to 72 hours post administration
Awards & highlights

Study Summary

This trial is studying a new way to treat people with inflammatory conditions by blocking a protein that is involved in these responses.

Eligible Conditions
  • Kidney Failure
  • Healthy Subjects
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose up to 72 hours post administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose up to 72 hours post administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration vs. time curve from zero to infinity (AUC) after single dose of BAY 2395840
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY 2395840
Unbound area under the concentration vs. time curve from zero to infinity (AUCu) after single (first) dose of BAY 2395840
+1 more
Secondary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: normal renal function aiming to balance out Group 2Experimental Treatment1 Intervention
Participants with normal renal function aiming to balance out Group 2 for the age and gender investigations will receive a single dose of BAY2395840.
Group II: Group 2: normal renal function matched to Group 1Experimental Treatment1 Intervention
Participants with normal renal function matched to Group 1 will receive a single dose of BAY2395840.
Group III: Group 1: moderately impaired renal functionExperimental Treatment1 Intervention
Participants with moderately impaired renal function will receive a single dose of BAY2395840.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY2395840
2022
Completed Phase 2
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BayerLead Sponsor
2,240 Previous Clinical Trials
25,332,749 Total Patients Enrolled
1 Trials studying Kidney Failure
168 Patients Enrolled for Kidney Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential perils exist from consuming BAY2395840?

"The safety of BAY2395840 was assessed at 1 due to its status as a Phase 1 trial, which has not yet gathered sufficient data on the medication's efficacy and security."

Answered by AI

Is there still room to join this experiment for potential participants?

"According to the details available on clinicaltrials.gov, this medical trial is not currently recruiting participants as it was last updated on November 7th 2022. Despite this, there are 1,155 other trials searching for volunteers at present."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Florida
Georgia
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Clinical Pharmacology of Miami, LLC
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m on drugs insulin and pills I want to not have to use them to survive.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function
2023. "A Study to Learn How the Study Treatment BAY2395840 Moves Into, Through and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Moderate Reduced Kidney Function and in Healthy Male and Female Participants With Normal Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05406219.
~0 spots leftby Apr 2025
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