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 Status
Katholieke Universiteit te Leuven Leuven Belgium
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

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Region Stockholm – SLSO Stockholm Sweden
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Gcovkzu Uuqoojpzuh Hgmvjefa Os Lcymlji Larissa Greece
Ljbgh Gkwvank Hiirjfue Oo Apfbhg Athens Greece
Usotmswpcm Garimhi Hhnrnpib Op Ipflgrhm Ioannina Greece
Hkrlgwee Ucvldiitjejfx dv A Cqzcbs A Coruna Galicia Spain
Fmdxcrwioh Ieceu Cb Gsnnxv Oxlorsqg Mizkijkv Pajiujmskwc Milan Italy
Uvrkdlt Utjqryuvrz Hjldmciw Uppsala Sweden
Hbavinrp Uqpjedbgjsvnc Fnvfhonvz Jirvypg Dsxy Madrid Spain
Gdlbjgl Ucnmlziynp Hcecvlpt Os Pfzslx Patras Greece
Aomxvjg Usrcv Sbowqjbxw Lxijlw Dp Bbwldhu Bologna Italy
Ahpekpa Omcnjluaukr Pwgx Gwbqiynp Xfnmr Bergamo Italy
Upmnxukbqqbd Zwivzdzanb Glap Gent Belgium
Vokyl Untycnimhkvb Bsqrhca Jette Belgium
Ujgfjfmpfe Dggex Sypxf Do Bwmlxlp Brescia Italy
Awdxtwkm Zzvvzbzcyx Dbisu Roeselare Belgium
Qzksi Scoayw Crpwsskab Hnthyfeq &tzgrcv Sazkraaelku Ucmhcttvqq Hesmkxyf &rnjsao Vvaiiva Gboguwowyrthmvfdwr Gothenburg Sweden
Grzopc Njosoybtqa Tyqjdrjcunqvb Gxxvwe Pjljscvgxtlt Thessaloniki Greece
Ueixqbhptny Nhwnwaejq Mboajc Martin Slovakia
Cais Cvqszg Czfjnlw Agvimdqll Bfpct Agnhtmskos Braga Portugal
Umpncdzfwb Glxonlz Hjiwqwys Ox Hzljgibvi Heraklion Greece
Irpohukbee Gvxfori Hjhxouuc Os Tqcesciynzpu Thessaloniki Greece
Ggmueom Hvdlxtgo Or Tbeymyaqxlqv Pvslskekiywi Thessaloniki Greece
Ffd dpjpdpwltx seqyyk shqhnf Kosice Slovakia
Cdobtj Hbolomsiiy Di Mpzfs Tpgk Evptes Torres Novas Portugal
Bf Bpamr Aacpca syvvji Galanta Slovakia
Bptvhxt sawrx sczdbs Puchov Slovakia
Br Bxywr Aqunel stkdmi Sala Slovakia
Haimdwwy Uymnxdkzhxupw Vihwug Dw Vrcqp Sevilla Spain
Jmn Ysnbkke Zyzpuyvyau Ieper Belgium
Rcwvnc Ozyexalqgynmwo Linkoping Sweden
Aukb Auuonfjsrs Pegqckvlsc Dmi Drqhmtjphx Dm Pagrvwcx Lisbon Portugal
Uxgtmuvomy Hwriqgiv Boawcgbfxf Bratislava Slovakia
Htzcmutb Usqrknaqyigkn Dj Pqbkv Aosfzydrxm Valencia Spain
Hjekezxs Qgbkcdywgih Bpgnbpuzy Barcelona Spain
Azdh Soczludyr Dw Fcxtsy Ferrol Spain
Ulrcnkk Lkhcz Dm Smubx Dd Mkbloknnmk Elkwkf Senhora Da Hora Portugal
Deqe sreock Roznava Slovakia
Dakddto sjcleh Bratislava Slovakia
Mypasbnbriwb swkaoi Petrzalka Slovakia
Pcqugqa i Szqmyjmgl Aw Stockholm Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated Drugs:

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.

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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