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BAY3283142 for Chronic Kidney Disease (ALPINE 1 Trial)

Phase 2
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be ≥18 years of age
eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) must be ≥20 and ≤75 mL/min /1.73 m^2 at Screening with one re-assessment allowed based on central laboratory values
Must not have
Polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, or any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening
History of secondary hypertension other than CKD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to find a better way to treat chronic kidney disease (CKD) by testing a new drug called BAY3283142. The drug is thought to reduce albumin in the urine

Who is the study for?
This trial is for adults over 18 with chronic kidney disease (CKD), specifically those with reduced kidney function and high levels of albumin in their urine. Participants should be on a stable dose of medication for managing blood pressure, diabetes, or kidney conditions for at least 4 weeks prior to the study. People with low blood pressure, recent severe cardiovascular events, serious liver disease, or who require immune system-controlling drugs for kidney issues cannot join.
What is being tested?
The trial is testing BAY3283142's effectiveness and safety in CKD patients by comparing it against a placebo while participants continue standard CKD treatments. The main goal is to see if BAY3283142 can reduce albumin levels in the urine over a period of 16 weeks. Participants will not know whether they are receiving the actual drug or the placebo during this time.
What are the potential side effects?
Potential side effects may include pain and discomfort from blood sample collection; however, specific side effects related to BAY3283142 are not detailed here but will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function, measured by eGFR, is between 20 and 75 mL/min.
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I've been on the highest dose I can handle of ACEI or ARB for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a kidney condition that needed immune system treatment in the last 6 months.
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I have high blood pressure caused by a condition other than chronic kidney disease.
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I have significant drops in blood pressure when standing.
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My blood pressure is under control with 3 or more medications.
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My liver is not working well (Child-Pugh B or C).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 6Experimental Treatment1 Intervention
BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days
Group II: Arm 5Experimental Treatment1 Intervention
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
Group III: Arm 4Experimental Treatment1 Intervention
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days
Group IV: Arm 3Experimental Treatment1 Intervention
BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days
Group V: Arm 2Experimental Treatment1 Intervention
BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days
Group VI: Arm 1Placebo Group1 Intervention
Placebo OD and sham titration after 14 days and after 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAY3283142
2023
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,275 Previous Clinical Trials
25,538,699 Total Patients Enrolled
~467 spots leftby May 2026
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