Study on the Effectiveness and Safety of BAY 3283142 in Reducing Urine Albumin for Patients with Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying a condition known as chronic kidney disease, which affects the kidneys’ ability to filter waste from the blood. The trial will evaluate a new treatment called BAY 3283142, which is taken as a coated tablet. The purpose of the study is to learn how well this new drug works and how safe it is in reducing the amount of a protein called albumin in the urine of people with chronic kidney disease. Albumin in the urine is a sign that the kidneys are not working as well as they should.

Participants in the study will be randomly assigned to receive either the new drug BAY 3283142 or a placebo, in addition to their standard care. The study will last for 16 weeks, during which time the participants will take the medication orally. The researchers will monitor changes in the urine albumin-creatinine ratio, which is a measure used to assess kidney function. This will help determine the most effective dose of the new drug for future studies.

Throughout the study, participants will have regular check-ups to monitor their kidney function and overall health. The study aims to find the best dose of BAY 3283142 to help reduce albumin in the urine, which could potentially improve kidney health in people with chronic kidney disease. The results of this study will help guide further research and development of this treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age and kidney function.

Participants must be 18 years or older and have a specific range of kidney function as measured by eGFR, a test that estimates how well the kidneys are filtering.

2 initial assessment

An initial assessment is conducted to establish baseline measurements, including urine tests to determine the albumin-creatinine ratio (UACR).

Participants must have a stable dose of certain medications for at least four weeks before this assessment.

3 treatment phase

Participants receive either the new drug BAY 3283142 or a placebo, both in the form of coated tablets taken orally.

The treatment lasts for 16 weeks, during which the effect on urine albumin levels is monitored.

4 monitoring visits

Regular visits are scheduled to monitor kidney function and any changes in the urine albumin-creatinine ratio.

These visits occur at specific intervals, referred to as Visits 5, 6, and 7, to track progress and any side effects.

5 end of treatment evaluation

At the end of the 16-week treatment period, a final evaluation is conducted to assess changes in kidney function and urine albumin levels.

The primary goal is to determine the effectiveness and safety of the new drug compared to the placebo.

Who Can Join the Study?

Participant must be at least 18 years old.
eGFR (a test that measures how well your kidneys are working) should be between 20 and 75 mL/min/1.73 m² at the time of screening. If needed, this test can be done again during the screening period.
UACR (a test that checks the amount of protein in your urine) should be between 200 mg/g and less than 3500 mg/g, based on the average of three morning urine samples taken during screening.
Participant should be on the highest tolerated dose of either ACEI (a type of medication that helps relax blood vessels) or ARB (another type of medication that helps relax blood vessels), unless they cannot tolerate it or it is not suitable for them. The dose should be stable for at least 4 weeks before screening, with no planned changes during the study.
If the participant is taking any of the following treatments, they should be stable for 4 weeks before screening: SGLT2 inhibitor (a medication that helps lower blood sugar), finerenone (a medication used for kidney and heart protection), diuretics (medications that help remove excess fluid from the body), endothelin-receptor antagonists (medications that help relax blood vessels), or GLP receptor agonist (medications that help control blood sugar).

Who Cannot Join the Study?

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent heart attack or stroke.
Patients with severe liver disease.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients who have an allergy to the study medication.
Patients who have had a kidney transplant.
Patients with uncontrolled high blood pressure.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Centre Hospitalier Epicura	Ath	Belgium
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Region Oestergoetland	Linkoping	Sweden
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
University Hospital Bratislava	Bratislava	Slovakia
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Univerzitna Nemocnica Martin	Martin	Slovakia
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
University General Hospital Of Heraklion	Heraklion	Greece
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Area Sanitaria De Ferrol	Ferrol	Spain
Region Stockholm – SLSO	Stockholm	Sweden
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Diabeda s.r.o.	Bratislava	Slovakia
Medispektrum s.r.o.	Petrzalka	Slovakia
ProbarE i Stockholm AB	Stockholm	Sweden
DIAB s.r.o.	Roznava	Slovakia
Hospital Quironsalud Barcelona	Barcelona	Spain
APDP Associacao Protectora Dos Diabeticos De Portugal	Lisbon	Portugal
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Da Luz S.A.	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Jan Yperman Ziekenhuis	Ieper	Belgium
General University Hospital Of Patras	Patras	Greece
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Vrije Universiteit Brussel	Jette	Belgium
Universita Degli Studi Di Brescia	Brescia	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Fyb deuzipedsf sgsukf spfhbk	Kosice	Slovakia
Bs Bmrrj Auwxbm sbaior	Sala	Slovakia
Btdbtnw sfdlx sstqmb	Puchov	Slovakia
Bl Bailq Aeerzm sifmwa	Galanta	Slovakia
Lqhec Glgsdmv Hxqomloq Ol Aomxxa	Athens	Greece
Uzguhlr Ufqrlrucjw Hvhsincw	Uppsala	Sweden
Aizmwux Utnpm Svqzmqhsg Lwaqpn Dx Bavwfce	Bologna	Italy
Abraxtg Ohrsgnbnypr Ppap Gbucrlss Xaioh	Bergamo	Italy
Hjjakbzs Uztrsknbrpphp dz A Cgjglz	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.08.2024
Greece	Not recruiting	30.08.2024
Italy	Not recruiting	30.08.2024
Portugal	Not recruiting	30.08.2024
Slovakia	Not recruiting	30.08.2024
Spain	Not recruiting	30.08.2024
Sweden	Not recruiting	30.08.2024

Trial locations

Investigated drugs:

Bay 3283142

BAY 3283142 is an investigational medication being studied for its potential to reduce albuminuria in patients with chronic kidney disease. Albuminuria is a condition where there is an excess amount of protein called albumin in the urine, which can be a sign of kidney damage. This medication is being tested to see how well it can lower the levels of albumin in the urine when used alongside standard treatments for chronic kidney disease. The study aims to find the most effective dose of this medication for future research.

Investigated diseases:

Chronic kidney disease

Chronic kidney disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses over time, often without noticeable symptoms in the early stages. As kidney function declines, waste products can build up in the body, leading to symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can lead to complications like high blood pressure, anemia, and bone disease. In advanced stages, the kidneys may fail completely, requiring dialysis or a kidney transplant. The rate of progression can vary depending on the underlying cause and individual health factors.

Trial ID:

2023-505755-40-00

Protocol code:

22040

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of BAY 3283142 in Reducing Urine Albumin for Patients with Chronic Kidney Disease

What is this study about?

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