do_not_disturb_altRecruitment Complete

Chronic kidney disease

A study to learn about how well BAY3283142 works and its safety in participants with chronic kidney disease

Trial purpose

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.
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.

Key Participants Requirements

Sex

All

Age

18 Years
  • - 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
  • - 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 summary

Enrollment Goal
700
Trial Dates
August 2024 - March 2026
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY3283142
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
SingHealth Polyclinics - Pasir RisSingapore, 519457, Singapore
Active, not recruiting
Southern Medical University - Nanfang Hospital (Southern Hospital)Guangzhou, 510515, China
Active, not recruiting
Centro de Especialidades Medicas (Cemedic) | Cardiology DepartmentVilla Luro, C1440CFD, Argentina
Active, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e TrapiantoBologna, 40138, Italy
Active, not recruiting
ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-DiabetologiaBergamo, 24127, Italy
Active, not recruiting
Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di ReneModena, 41124, Italy
Active, not recruiting
Istituti Clinici Scientifici Maugeri S.p.A._Pavia - NefrologiaPavia, 27100, Italy
Active, not recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e DialisiMessina, 98124, Italy
Withdrawn
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - NefrologiaBrescia, 25123, Italy
Active, not recruiting
Centro Hospitalar de Lisboa Ocidental | Clinical Research DepartmentCarnaxide, 2790-134, Portugal
Active, not recruiting
Hospital Garcia de Orta | Research DepartmentAlmada, 2805-267, Portugal
Active, not recruiting
Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology DepartmentLisboa, 1069-166, Portugal
Active, not recruiting
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'Thessaloniki, 54642, Greece
Active, not recruiting
Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou)Thessaloniki, 570 10, Greece
Completed
General Hospital of Athens LAIKOAthens, 11527, Greece
Active, not recruiting
University General Hospital of Heraklion - Department of PaediatricsHeraklion, 71110, Greece
Active, not recruiting
University of Thessaly - General University Hospital of Larissa (UHL)Larissa, 41100, Greece
Active, not recruiting
University Hospital of Ioannina (UHI)Nisos Ioanninon, 455 00, Greece
Active, not recruiting
University General Hospital of Patras | Nephrology ClinicPatra, 26504, Greece
Active, not recruiting
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Active, not recruiting
Centro Clinico Academico Braga | Braga, PortugalBraga, 4710-243, Portugal
Active, not recruiting
CHUC- Hospitais da Universidade de Coimbra - Nephrology DepartmentCoimbra, 3000-075, Portugal
Active, not recruiting
AZ Delta / NephrologyRoeselare, 8800, Belgium
Active, not recruiting
UZ Gent / NephrologyGent, 9000, Belgium
Active, not recruiting
Hospital de Vila Franca de Xira | Centro de Desenvolvimento e InvestigacaoVila Franca de Xira, 2600-009, Portugal
Active, not recruiting
Hospital Pedro Hispano | Clinical Research CenterMatosinhos, 4464-513, Portugal
Active, not recruiting
Centro de Rehabilitacion Cardiovascular | San Luis, ArgentinaSan Luis, D5702AAX, Argentina
Active, not recruiting
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology DepartmentTorres Novas, 2350-754, Portugal
Active, not recruiting
UZ Leuven / NephrologyLeuven, 3000, Belgium
Active, not recruiting
CEDIC Centro de Investigación Clínica | Buenos Aires, ArgentinaCABA, C1018DES, Argentina
Active, not recruiting
Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, ArgentinaCiudad Autónoma de Buenos Aire, C1056ABI, Argentina
Active, not recruiting
Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, ArgentinaSanta Rosa, Argentina
Active, not recruiting
DIAB s.r.oRoznava, 048 01, Slovakia
Active, not recruiting
Barts Health NHS Trust - Royal London Hospital - NephrologyLondon, E1 1FR, United Kingdom
Active, not recruiting
Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials UnitCarshalton, SM5 1AA, United Kingdom
Active, not recruiting
Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research DepartmentHull, HU3 2JZ, United Kingdom
Active, not recruiting
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and TransplantCardiff, CF14 4XW, United Kingdom
Active, not recruiting
Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - NephrologySalford, M6 8HD, United Kingdom
Withdrawn
Royal Free London NHS Foundation Trust | Royal Free Hospital – Cancer ServicesLondon, NW3 2QG, United Kingdom
Active, not recruiting
University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research FacilityBirmingham, B15 2TH, United Kingdom
Active, not recruiting
King’s College Hospital NHS Foundation Trust | King's College Hospital - Renal Research DepartmentLondon, SE5 9RJ, United Kingdom
Active, not recruiting
Lakeside Healthcare | Lakeside Surgery - Research DepartmentNorthamptonshire, NN17 2UR, United Kingdom
Active, not recruiting
Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal CareManchester, M13 9WL, United Kingdom
Active, not recruiting
Balboa Research SMO+ - Chula Vista - WestChula Vista, 91910, United States
Active, not recruiting
Clinical Advancement Center, PLLCSan Antonio, 78212, United States
Active, not recruiting
Eastern Nephrology Associates - New BernNew Bern, 28562, United States
Active, not recruiting
Florida Institue for Clinical ResearchOrlando, 32825, United States
Active, not recruiting
Knoxville Kidney Center, PLLCKnoxville, 37923-3624, United States
Completed
Manassas Clinical Research CenterManassas, 20110, United States
Active, not recruiting
Mendez Center For Clinical Research | Woodbridge, VAWoodbridge, 22192, United States
Active, not recruiting
Nephrology Associates of Northern Illinois and Indiana - HinsdaleHinsdale, 60521, United States
Active, not recruiting
Brookview Hills Research Associates, LLCWinston-Salem, 27103, United States
Active, not recruiting
Peninsula Kidney Associates - HamptonHampton, 23666, United States
Active, not recruiting
Southeastern Clinical Research Institute, LLCAugusta, 30904, United States
Active, not recruiting
Utah Kidney Research Institute | Salt Lake City, UTSouth Salt Lake, 84115, United States
Active, not recruiting
Yale University School of MedicineNew Haven, 06510, United States
Active, not recruiting
Nephrology Consultants, LLCHuntsville, 35805-4104, United States
Completed
Balboa Research SMO+ - La MesaLa Mesa, 91942, United States
Active, not recruiting
Renal Disease Research Institute | LandryDallas, 75246, United States
Withdrawn
DaVita Clinical Research | North Houston, TXShenandoah, 77384, United States
Active, not recruiting
Triad Internal Medicine - AsheboroAsheboro, 27203, United States
Active, not recruiting
Nova Clinical Research - Blake Medical CenterBrandenton, 34209, United States
Withdrawn
DaVita Clinical Research | Westover Hills, San Antonio, TXSan Antonio, 78251, United States
Active, not recruiting
Renstar Medical Research - Deerwood ClinicOcala, 34471, United States
Not yet recruiting
Elixia Central FloridaOrlando, 32608, United States
Active, not recruiting
Research by Design, LLC | Chicago, ILChicago, 60643, United States
Active, not recruiting
California Kidney Specialists - San DimasSan Dimas, 91773, United States
Active, not recruiting
Vanderbilt University Medical CenterNashville, 37232, United States
Completed
Salem VA Medical Center - CardiologySalem, 24153, United States
Active, not recruiting
Southwest Houston Research, Ltd.Houston, 77099, United States
Active, not recruiting
Chubu Rosai HospitalNagoya, 455-8530, Japan
Active, not recruiting
Ehime Prefectural Central HospitalMatsuyama, 790-0024, Japan
Active, not recruiting
Fukui Prefectural HospitalFukui-shi, 910-0846, Japan
Withdrawn
JA Toride Medical CenterToride, 302-0022, Japan
Active, not recruiting
Japanese Red Cross Fukuoka HospitalFukuoka, 815-8555, Japan
Active, not recruiting
Japanese Red Cross Saitama HospitalSaitama, 330-8553, Japan
Completed
Jiyugaoka Yamada Internal Medicine ClinicObihiro, 080-0848, Japan
Active, not recruiting
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Active, not recruiting
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Active, not recruiting
Komatsu Municipal HospitalKomatsu City, 923-8560, Japan
Active, not recruiting
Hirohata Naika ClinicKitakyushu, 807-0857, Japan
Active, not recruiting
Naka Kinen ClinicNaka-shi, 311-0113, Japan
Active, not recruiting
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Active, not recruiting
Osaka General Medical CenterOsaka, 558-8558, Japan
Active, not recruiting
Saiseikai Matsuyama HospitalMatsuyama, 791-8026, Japan
Active, not recruiting
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-0054, Japan
Active, not recruiting
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Active, not recruiting
University of Yamanashi HospitalChuo, 409-3898, Japan
Active, not recruiting
Yokohama City University HospitalYokohama, 236-0004, Japan
Completed
Katta General HospitalShiroishi, 989-0231, Japan
Active, not recruiting
Kasugai Municipal HospitalKasugai, 486-8510, Japan
Active, not recruiting
NTT Medical Center TokyoShinagawa-ku, 141-8625, Japan
Active, not recruiting
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Completed
Rinku General Medical CenterIzumisano, 598-0048, Japan
Active, not recruiting
Steel Memorial Yawata HospitalKitakyusyu, 805-8508, Japan
Completed
Hospital Universitario Nuestra Senora de Valme | Internal Medicine DepartmentSevilla, 41014, Spain
Active, not recruiting
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and NutritionA Coruna, 15006, Spain
Active, not recruiting
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialFerrol, 15405, Spain
Active, not recruiting
Hospital Quironsalud Barcelona | Internal Medicine DepartmentBarcelona, 8023, Spain
Active, not recruiting
Hospital Universitario Y Politecnico La Fe - NefrologiaValencia, 46026, Spain
Active, not recruiting
Hospital Universitario Doctor Peset | Nephrology DepartmentValencia, 46017, Spain
Active, not recruiting
Hospital Universitario Ramon Y Cajal - Medicina InternaMadrid, 28034, Spain
Active, not recruiting
Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension DepartmentMadrid, 28040, Spain
Active, not recruiting
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology DepartmentL'Hospitalet de Llobregat, 8907, Spain
Completed
Hospital Clinico Universitario de Valencia | Nephrology DepartmentMISSING, 46010, Spain
Active, not recruiting
Epicura / NephrologyBaudour, 7331, Belgium
Active, not recruiting
Jan Yperman Ziekenhuis / NephrologyIeper, 8900, Belgium
Active, not recruiting
UZ Brussel NephrologyJette, 1090, Belgium
Active, not recruiting
Universitetssjukhuset i LinköpingLInköping, 581 85, Sweden
Active, not recruiting
Sahlgrenska Universitetssjukhuset - NjurklinikenGothenburg, 413 45, Sweden
Completed
Akademiska sjukhuset (Uppsala University Hospital) - NjurklinikenUppsala, 751 85, Sweden
Active, not recruiting
Center For Diabetes, Academic Specialist CenterStockholm, 113 65, Sweden
Active, not recruiting
ProbareE StockholmStockholm, 113 29, Sweden
Active, not recruiting
Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios ClinicosLisbon, 1250-189, Portugal
Active, not recruiting
Centro Privado San Vicente DiabetesCórdoba, 5000, Argentina
Active, not recruiting
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)Buenos Aires, C1431FWO, Argentina
Active, not recruiting
Centro de Investigaciones Medicas Temperley | Buenos Aires, ArgentinaTemperley, B1834GUK, Argentina
Active, not recruiting
Biodial | Puchov, SlovakiaPuchov, 02001, Slovakia
Active, not recruiting
NephroCare | FMC-dialyzacne sluzby s.r.o. - KosiceKosice, 04011, Slovakia
Active, not recruiting
B. Braun Avitum Nefrologicka Ambulancia | Galanta, SlovakiaGalanta, 924 22, Slovakia
Completed
B. Braun Avium Nefrologicka ambulancia | Sala, SlovakiaSala, 92719, Slovakia
Completed
MEDISPEKTRUM s.r.o.Bratislava, 85101, Slovakia
Active, not recruiting
DIABEDA s.r.o.Bratislava, 83106, Slovakia
Active, not recruiting
Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulanciaBratislava, 83101, Slovakia
Completed
Univerzitna nemocnica MartinMartin, 036 59, Slovakia
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Active, not recruiting
The Second Affiliated Hospital of Nanjing Medical universitynanjing, 210000, China
Active, not recruiting
Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)Nanjing, 210029, China
Completed
The Third Xiangya Hospital of Central South Universitychangsha, 410000, China
Active, not recruiting
Shanxi Bethune HospitalTaiyuan, 030032, China
Active, not recruiting
The First Affiliated Hospital of Xiamen UniversityXiamen, 361003, China
Active, not recruiting
Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)Beijing, 100029, China
Active, not recruiting
Huadong Hospital, Affiliated to Fudan UniversityShanghai, 200040, China
Active, not recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)Chengdu, 610072, China
Active, not recruiting
Sichuan University - West China HospitalChengdu, 610041, China
Active, not recruiting
Shandong Provincial HospitalJinan, 250021, China
Active, not recruiting
Peking University People's HospitalBeijing, 100032, China
Withdrawn
Shandong Provincial HospitalJinan, 250021, China
Active, not recruiting
Renji Hospital Shanghai JiaoTong University of MedicineShanghai, 200001, China
Active, not recruiting
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Active, not recruiting
The Second Hospital of Jilin UniversityChangchun, 130000, China
Withdrawn
Asan Medical Center - Oncology DepartmentSeoul, 5505, Korea,_republic_of
Withdrawn
Korea University Anam HospitalSeoungbuk-gu, 02841, Korea,_republic_of
Withdrawn
Samsung Medical Center - Oncology DepartmentSeoul, 06351, Korea,_republic_of
Withdrawn
Severance Hospital, Yonsei University Health SystemSeoul, 3722, Korea,_republic_of
Withdrawn
Korea University Ansan HospitalGyeonggi-do, 425-707, Korea,_republic_of
Withdrawn
Yonsei University Wonju Christian HospitalWonju, 26426, Korea,_republic_of
Withdrawn
Hallym University Sacred Heart HospitalAnyang-si, 14068, Korea,_republic_of
Withdrawn
Marengo Asia Hospital, GurugramGurugram, 122011, India
Active, not recruiting
Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)New Delhi, 110017, India
Active, not recruiting
The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)Calcutta, 700020, India
Active, not recruiting
Mavani Research CenterAhmedabad, 380052, India
Active, not recruiting
Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))Bangalore, 560092, India
Active, not recruiting
All India Institute of Medical Sciences (AIIMS) - New DelhiNew Delhi, 110 029, India
Active, not recruiting
Madras Diabetes Research FoundationChennai, 600 086, India
Active, not recruiting
Singapore General HospitalSingapore, 169608, Singapore
Withdrawn
Khoo Teck Puat HospitalSingapore, 768828, Singapore
Active, not recruiting
Changi General HospitalSingapore, 529889, Singapore
Active, not recruiting
National University Hospital Medical CentreSingapore, 119074, Singapore
Active, not recruiting
Tan Tock Seng HospitalSingapore, 308433, Singapore
Active, not recruiting
The First People's Hospital - FoshanFoshan, 528000, China
Withdrawn
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di ReneMilano, 20122, Italy
Active, not recruiting
Far Eastern Memorial HospitalNew Taipei, 220, Taiwan
Active, not recruiting
Chi-Mei Medical Center, LiouyineTainan, 736, Taiwan
Active, not recruiting
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Active, not recruiting
National Heart Centre SingaporeSingapore, 169609, Singapore
Active, not recruiting
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Active, not recruiting
Changhua Christian HospitalChanghua, 50006, Taiwan
Active, not recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Active, not recruiting
Taizhou Hospital of Zhejiang ProvinceTaizhou, 317099, China

Primary Outcome

  • Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)
    date_rangeTime Frame:
    From baseline to Week 16

Secondary Outcome

  • Change from baseline over time in estimated glomerular filtration rate (eGFR)
    date_rangeTime Frame:
    From baseline to Week 16
  • Change from baseline over time in the logarithm of UACR
    date_rangeTime Frame:
    From baseline to Week 16
  • Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs leading to permanent discontinuation of study intervention
    date_rangeTime Frame:
    From the first dose of study intervention up to 7 days after last intake of study intervention, up to 17 Weeks per each participant

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
6