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Chronic Kidney DiseasePhase 2ALPINE 1NCT06522997

A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease

A Phase 2 study testing BAY3283142 in people with Chronic Kidney Disease, run by Bayer at 153 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A common sign of decreasing kidney function is the body losing too much of a protein called albumin in the urine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
BAY3283142
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,222 participants
Where
153 sitesin 15 countries
Study dates
8 Aug 2024to 20 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be ≥18 years of age
  • eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m^2 at Screening Note: One re-assessment of eGFR based on central laboratory values is allowed during the Screening period"
  • UACR ≥200 mg/g and <3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at Screening
  • Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study
  • If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist

Who cannot join

  • Systolic blood pressure (SBP) <100 mmHg at Visit 2 (baseline)
  • Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator
  • SBP ≥160 mmHg, unless treated with ≥3 blood pressure lowering medications, at Screening or at Visit 2 (baseline)
  • History of secondary hypertension other than CKD
  • Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening
  • Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening

Trial locations and contacts

153 sites in 15 countries.

153 sites in 15 countries

United States24 sites

  • Triad Internal Medicine - Asheboro

    Asheboro, North Carolina, 27203

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30904

  • Nova Clinical Research - Blake Medical Center

    Bradenton, Florida, 34209

  • Research by Design, LLC | Chicago, IL

    Chicago, Illinois, 60643

  • Balboa Research SMO+ - Chula Vista

    Chula Vista, California, 91910

  • Renal Disease Research Institute | Landry

    Dallas, Texas, 75246

  • Peninsula Kidney Associates - Hampton

    Hampton, Virginia, 23666

  • Nephrology Associates of Northern Illinois and Indiana - Hinsdale

    Hinsdale, Illinois, 60521

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Vanderbilt University Medical Center - Nephrology Clinical Trials Center

    Nashville, Tennessee, 37232

  • Eastern Nephrology Associates - New Bern

    New Bern, North Carolina, 28562

  • Yale Nephrology Clinical Research Clinic

    New Haven, Connecticut, 06510

  • Renstar Medical Research - Deerwood Clinic

    Ocala, Florida, 34471

  • Elixia Central Florida

    Orlando, Florida, 32608

  • Florida Institue for Clinical Research

    Orlando, Florida, 32825

  • Salem VA Medical Center - Nephrology

    Salem, Virginia, 24153

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • California Kidney Specialists - San Dimas

    San Dimas, California, 91773

  • Utah Kidney Research Institute | Salt Lake City, UT

    South Salt Lake, Utah, 84115

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

  • Mendez Center For Clinical Research | Woodbridge, VA

    Woodbridge, Virginia, 22192

Other trials in United States

Japan24 sites

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898

  • Fukui Prefectural Hospital

    Fukui-shi, Fukui, 910-0846

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Kasugai Municipal Hospital

    Kasugai, Aichi-ken, 486-8510

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Steel Memorial Yawata Hospital

    Kitakyushu, Fukuoka, 805-8508

  • Hirohata Naika Clinic

    Kitakyushu, Fukuoka, 807-0857

  • Komatsu Municipal Hospital

    Komatsu, Ishikawa-ken, 923-8560

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime, 791-8026

  • Chubu Rosai Hospital

    Nagoya, Aichi-ken, 455-8530

  • Naka Kinen Clinic

    Naka, Ibaraki, 311-0113

  • Nara Prefecture General Medical Center

    Nara, 630-8581

  • Jiyugaoka Yamada Internal Medicine Clinic

    Obihiro, Hokkaido, 080-0848

  • Osaka General Medical Center

    Osaka, 558-8558

  • Japanese Red Cross Saitama Hospital

    Saitama, 330-8553

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • Katta General Hospital

    Shiroishi, Miyagi, 989-0231

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba, 279-0021

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama, Kanagawa, 234-0054

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

China18 sites

  • Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)

    Beijing, 100029

  • Peking University People's Hospital

    Beijing, 100044

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Sichuan University - West China Hospital

    Chengdu, 610041

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)

    Chengdu, 610072

  • The First People's Hospital - Foshan

    Foshan, 528000

  • The First Affiliated Hospital of Guangzhou University of TCM

    Guangzhou, Guangdong, 510405

  • Southern Medical University - Nanfang Hospital (Southern Hospital)

    Guangzhou, 510515

  • Huai'an First People's Hospital, Nanjing Medical University

    Huai'an, Jiangsu, 223300

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • The Second Affiliated Hospital of Nanjing Medical university

    Nanjing, Jiangsu, 210011

  • Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)

    Nanjing, 210029

  • Renji Hospital Shanghai JiaoTong University of Medicine

    Shanghai, 200001

  • Huadong Hospital, Affiliated to Fudan University

    Shanghai, 200040

  • Shanxi Bethune Hospital

    Taiyuan, 030032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

Portugal10 sites

  • Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department

    Almada, Setúbal District, 2805-267

  • Centro Clinico Academico Braga | Braga, Portugal

    Braga, 4710-243

  • Unidade Local De Saúde De Lisboa Ocidental E.P.E.

    Carnaxide, Lisbon District, 2790-134

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Nefrologia

    Coimbra, 3000-075

  • Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department

    Lisbon, 1069-166

  • Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos

    Lisbon, 1250-189

  • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica

    Lisbon, 1500-650

  • Hospital Pedro Hispano | Clinical Research Center

    Matosinhos Municipality, Porto District, 4464-513

  • Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department

    Torres Novas, Santarém District, 2350-754

  • Unidade Local de Saude do Estuario do Tejo | Hospital de Vila Franca de Xira - Departamento de Formacao e Investigacao

    Vila Franca de Xira, Lisbon District, 2600-009

Other trials in Portugal

Spain10 sites

  • Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion

    A Coruña, 15006

  • Hospital Quironsalud Barcelona | Internal Medicine Department

    Barcelona, 8023

  • Area Sanitaria De Ferrol | Medicina Interna

    Ferrol, A Coruña, 15405

  • Bellvitge Hospital Universitari | Nefrologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Ramon Y Cajal | Medicina Interna

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department

    Madrid, 28040

  • Hospital Universitario Virgen De Valme | Medicina Interna

    Seville, 41014

  • Hospital Clinico Universitario De Valencia | Nefrologia

    Valencia, 46010

  • Hospital Universitario Dr Peset Aleixandre | Nefrologia

    Valencia, 46017

  • Hospital Universitario Y Politecnico La Fe | Nefrologia

    Valencia, 46026

Other trials in Spain

Slovakia9 sites

  • Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia

    Bratislava, 83101

  • DIABEDA s.r.o.

    Bratislava, 83106

  • MEDISPEKTRUM s.r.o.

    Bratislava, 85101

  • B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia

    Galanta, 924 22

  • NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice

    Košice, 04011

  • Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenie

    Martin, 036 59

  • BIODIAL spol. s r.o.

    Púchov, 02001

  • DIAB s.r.o

    Rožňava, 048 01

  • B. Braun Avitum Nefrologicka ambulancia | Sala, Slovakia

    Šaľa, 92719

Other trials in Slovakia

United Kingdom9 sites

  • University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility

    Birmingham, West Midlands, B15 2TH

  • Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant

    Cardiff, Wales, CF14 4XW

  • Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit

    Carshalton, Surrey, SM5 1AA

  • Lakeside Healthcare | Lakeside Surgery - Research Department

    Corby, Northamptonshire, NN17 2UR

  • Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department

    Hull, East Riding Of Yorkshire, HU3 2JZ

  • Barts Health NHS Trust - Royal London Hospital - Nephrology

    London, Greater London, E1 1FR

  • King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department

    London, Greater London, SE5 9RJ

  • Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care

    Manchester, Greater Manchester, M13 9WL

  • Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

Argentina8 sites

  • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

    Buenos Aires, C1431FWO

  • CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina

    CABA, Ciudad Auton. de Buenos Aires, C1018DES

  • Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina

    Ciudad Autónoma de Buenos Aire, Buenos Aires, C1056ABI

  • Centro Privado San Vicente Diabetes

    Córdoba, 5000

  • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

    San Luis, San Luis Province, D5700CGR

  • Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina

    Santa Rosa, 0

  • Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina

    Temperley, Buenos Aires, B1834GUK

  • Centro de Especialidades Medicas (Cemedic) | Cardiology Department

    Villa Luro, Ciudad Auton. de Buenos Aires, C1440CFD

Other trials in Argentina

Greece8 sites

  • Laiko General Hospital Of Athens_ Department of Nephrology and Renal Transplantation

    Athens, 11525

  • General Hospital Of Thessaloniki Papageorgiou-Renal Department

    Efkarpia, Thessaloniki, 56429

  • University General Hospital of Heraklion-Nephrology Clinic

    Heraklion, 71500

  • University General Hospital Of Ioannina-Nephrology Clinic

    Ioannina, 45500

  • General University Hospital Of Larissa-Nephrology Clinic

    Larissa, 41100

  • University General Hospital of Patras | Nephrology Clinic

    Pátrai, Achaia, 26504

  • Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology

    Thessaloniki, 54642

  • Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department

    Thessaloniki, 57010

Other trials in Greece

Belgium6 sites

  • Epicura / Nephrology

    Baudour, 7331

  • UZ Gent / Nephrology

    Ghent, 9000

  • Jan Yperman Ziekenhuis / Nephrology

    Ieper, 8900

  • UZ Brussel Nephrology

    Jette, 1090

  • UZ Leuven / Nephrology

    Leuven, 3000

  • AZ Delta / Nephrology

    Roeselare, 8800

Other trials in Belgium

India6 sites

  • Mavani Research Center

    Ahmedabad, Gujarat, 380052

  • Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))

    Bengaluru, Karnataka, 560092

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)

    Kolkata, West Bengal, 700020

  • Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)

    New Delhi, National Capital Territory of Delhi, 110017

  • All India Institute of Medical Sciences (AIIMS) - New Delhi

    New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

Singapore6 sites

  • National University Hospital Medical Centre

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • National Heart Centre Singapore

    Singapore, 169609

  • Tan Tock Seng Hospital

    Singapore, 308433

  • SingHealth Polyclinics - Pasir Ris

    Singapore, 519457

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Italy5 sites

  • ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia

    Bergamo, 24127

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi

    Messina, 98124

  • Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene

    Modena, 41124

  • Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia

    Pavia, 27100

Other trials in Italy

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset - Njurkliniken

    Gothenburg, Västra Götaland County, 413 45

  • Universitetssjukhuset i Linköping

    Linköping, Östergötland County, 581 85

  • ProbareE Stockholm

    Stockholm, Stockholm County, 113 29

  • Center For Diabetes, Academic Specialist Center

    Stockholm, Stockholm County, 113 65

  • Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, Changhua, 50006

  • Chang Gung Memorial Hospital Kaohsiung

    Kaohsiung City, 833

  • Far Eastern Memorial Hospital

    New Taipei City, New Taipei, 220

  • Chi-Mei Medical Center, Liouyine

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Phase 2b Dose-finding, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of BAY 3283142 on Top of Standard of Care in Reducing Albuminuria in Patients With Chronic Kidney Disease

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A common sign of decreasing kidney function is the body losing too much of a protein called albumin in the urine. This condition is known as albuminuria. This can lead to a faster decline in kidney function. People who have high blood pressure and diabetes are more likely to have CKD and are at a higher risk of complications related to it.

BAY3283142 is a new drug that is being developed to treat people with CKD. It works by activating a protein that helps relax blood vessels and is thought to have beneficial effects in CKD.

Read more

In this study, researchers want to learn about how well different doses of BAY3283142 work when taken with standard treatment for CKD in reducing albumin in the urine of participants with CKD. They will compare the results of the change in the urine albumin-creatinine ratio (UACR) after 16 weeks for BAY3283142 with a placebo. A placebo looks like the study drug but does not have any medicine in it.

During the study, participants will take either of the following drugs:

  • BAY3283142: Participants will take BAY3283142 as tablets by mouth.
  • Placebo: Participants will take it in the same way as BAY3283142. Participants will continue taking the available standard treatment for CKD and other conditions they may have (for example, heart conditions and diabetes).

At the start of this study, the researchers will check the medical history and current medications of the participants. They will also perform a complete health check-up of all the participants. Researchers will take urine and blood samples from the participants at different time points to measure UACR and eGFR.

Participants will be divided equally into different groups. Only 1 group will receive placebo and the other groups will receive BAY3283142. Participants will take their assigned treatment for 16 weeks.

No one will know who receives which drug or dose of BAY3283142 during the study.

Participants will be in this study for around 23 weeks. This includes the time for screening before the start of treatment and follow-up with participants after treatment.

People can join this study if they:

  • are 18 years of age or older and have been diagnosed with CKD
  • have poor kidney function according to the eGFR test
  • have abnormally high levels of albumin in the urine according to the UACR test
  • have been taking certain drugs at a stable dose for management of high blood pressure, diabetes, kidney disease, etc. for at least 4 weeks before the start of the study

People cannot join this study if they:

  • have low blood pressure
  • have had a stroke or a heart attack, or were hospitalized because of heart failure in the 3 months before the start of the study
  • have a serious liver disease
  • have a kidney disease for which they need to take drugs that control the immune system The detailed requirements will be discussed between the study doctors and people considering joining this study.

Participants may or may not get the expected benefits of treatment with BAY3283142, but they will receive thorough medical check-ups during this study. These can help to improve individual treatment in the future and to identify unknown medical risks.

Some participants may experience medical problems during this study including pain and discomfort when blood samples are taken. Researchers will closely monitor and manage any medical problems the participants may have. They will not include people who should not take BAY3283142 due to known safety concerns.

The findings from this study may contribute to developing a new treatment option for people with CKD who have excess albumin in the urine.

Being tested
BAY3283142, Placebo
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY3283142Drug

    Tablet, intake orally once daily

  • PlaceboDrug

    Matching with BAY3283142

Study groups in NCT06522997
Study groupRoleWhat they receive
Arm 1Placebo comparatorPlacebo OD and sham titration after 14 days and after 28 days
Receives: Drug: Placebo
Arm 2ExperimentalBAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days
Receives: Drug: BAY3283142
Arm 3ExperimentalBAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days
Receives: Drug: BAY3283142
Arm 4ExperimentalBAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days
Receives: Drug: BAY3283142
Arm 5ExperimentalBAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
Receives: Drug: BAY3283142
Arm 6ExperimentalBAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days
Receives: Drug: BAY3283142

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)

    Measured: From baseline to Week 16

Secondary outcomes (3)

  1. Change from baseline over time in estimated glomerular filtration rate (eGFR)

    Measured: From baseline to Week 16

  2. Change from baseline over time in the logarithm of UACR

    Measured: From baseline to Week 16

  3. Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention

    Measured: From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start8 Aug 2024
  3. Primary completion24 Oct 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
5+1 parallel-arm
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06522997
Sponsor's protocol ID
22040
Other IDs
2023-505755-40-00, 2023
Acronym
ALPINE 1
Status last verified
Apr 2026
First submitted
22 Jul 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers' patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY3283142 in people with Chronic Kidney Disease, run by Bayer at 153 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, Japan, China, Portugal, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR) (time frame: From baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06522997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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