account_circleRecruiting
Chronic kidney disease
Bayer Identifier:
22040
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2023-505755-40-00
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.
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
AllAge
18 YearsTrial summary
Enrollment Goal
700Trial Dates
August 2024 - March 2026Phase
Phase 2Could I Receive a placebo
YesProducts
BAY3283142 Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | SingHealth Polyclinics - Pasir Ris | Singapore, 519457, Singapore |
Recruiting | Southern Medical University - Nanfang Hospital (Southern Hospital) | Guangzhou, 510515, China |
Recruiting | Centro de Especialidades Medicas (Cemedic) | Cardiology Department | Villa Luro, C1440CFD, Argentina |
Recruiting | Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto | Bologna, 40138, Italy |
Recruiting | ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia | Bergamo, 24127, Italy |
Recruiting | Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di Modena | Modena, 41124, Italy |
Recruiting | Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia | Pavia, 27100, Italy |
Recruiting | Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi | Messina, 98124, Italy |
Not yet recruiting | Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia | Brescia, 25123, Italy |
Recruiting | Centro Hospitalar de Lisboa Ocidental | Clinical Research Department | Carnaxide, 2790-134, Portugal |
Recruiting | Hospital Garcia de Orta | Research Department | Almada, 2805-267, Portugal |
Recruiting | Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department | Lisboa, 1069-166, Portugal |
Recruiting | Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit' | Thessaloniki, 54642, Greece |
Recruiting | Hellenic Republic Ministry of Health & Welfare - General Hospital of Thessaloniki (George Papanikolaou) | Thessaloniki, 570 10, Greece |
Recruiting | General Hospital of Athens LAIKO | Athens, 11527, Greece |
Recruiting | University General Hospital of Heraklion - Department of Paediatrics | Heraklion, 71110, Greece |
Not yet recruiting | University of Thessaly - General University Hospital of Larissa (UHL) | Larissa, 41100, Greece |
Recruiting | University Hospital of Ioannina (UHI) | Nisos Ioanninon, 455 00, Greece |
Recruiting | University General Hospital of Patras | Nephrology Clinic | Patra, 26504, Greece |
Not yet recruiting | General Hospital of Thessaloniki Papageorgiou | Thessaloniki, 56403, Greece |
Recruiting | Centro Clinico Academico Braga | Braga, Portugal | Braga, 4710-243, Portugal |
Recruiting | CHUC- Hospitais da Universidade de Coimbra - Nephrology Department | Coimbra, 3000-075, Portugal |
Recruiting | AZ Delta / Nephrology | Roeselare, 8800, Belgium |
Not yet recruiting | UZ Gent / Nephrology | Gent, 9000, Belgium |
Recruiting | Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao | Vila Franca de Xira, 2600-009, Portugal |
Recruiting | Hospital Pedro Hispano | Clinical Research Center | Matosinhos, 4464-513, Portugal |
Recruiting | Centro de Rehabilitacion Cardiovascular | San Luis, Argentina | San Luis, D5702AAX, Argentina |
Recruiting | Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department | Torres Novas, 2350-754, Portugal |
Not yet recruiting | UZ Leuven / Nephrology | Leuven, 3000, Belgium |
Recruiting | CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina | CABA, C1018DES, Argentina |
Recruiting | Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina | Ciudad Autónoma de Buenos Aire, C1056ABI, Argentina |
Recruiting | Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina | Santa Rosa, Argentina |
Recruiting | DIAB s.r.o | Roznava, 048 01, Slovakia |
Recruiting | Royal London Hospital | London, E1 1FR, United Kingdom |
Recruiting | Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit | Carshalton, SM5 1AA, United Kingdom |
Recruiting | Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department | Hull, HU3 2JZ, United Kingdom |
Recruiting | Cardiff and Vale University Health Board - University Hospital of Wales (UHW) | Cardiff, CF14 4XW, United Kingdom |
Recruiting | Salford Royal Hospital | Salford, M6 8HD, United Kingdom |
Withdrawn | Royal Free London NHS Foundation Trust - The Royal Free Hospital (RFH) | London, NW3 2QG, United Kingdom |
Recruiting | Queen Elizabeth Hospital | Birmingham, B15 2TH, United Kingdom |
Not yet recruiting | King’s College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department | London, SE5 9RJ, United Kingdom |
Recruiting | Lakeside Healthcare Research Department | Northamptonshire, NN17 2UR, United Kingdom |
Not yet recruiting | Manchester Royal Infirmary | Manchester, M13 9WL, United Kingdom |
Recruiting | Balboa Research SMO+ - Chula Vista - West | Chula Vista, 91911, United States |
Recruiting | Clinical Advancement Center, PLLC | San Antonio, 78212, United States |
Recruiting | Eastern Nephrology Associates - New Bern | New Bern, 28562, United States |
Recruiting | Florida Institue for Clinical Research | Orlando, 32825, United States |
Recruiting | Knoxville Kidney Center, PLLC | Knoxville, 37923-3624, United States |
Recruiting | Manassas Clinical Research Center | Manassas, 20110, United States |
Recruiting | Mendez Center For Clinical Research | Woodbridge, VA | Woodbridge, 22192, United States |
Recruiting | Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale | Hinsdale, 60521, United States |
Recruiting | Brookview Hills Research Associates, LLC | Winston-Salem, 27103, United States |
Recruiting | Peninsula Kidney Associates | Hampton, 23666, United States |
Recruiting | Southeastern Clinical Research Institute, LLC | Augusta, 30904, United States |
Active, not recruiting | Utah Kidney Research Institute | Salt Lake City, UT | South Salt Lake, 84115, United States |
Not yet recruiting | Yale University School of Medicine | New Haven, 06510, United States |
Recruiting | Nephrology Consultants, LLC | Huntsville, 35805-4104, United States |
Recruiting | Balboa Research SMO+ - La Mesa | La Mesa, 91942, United States |
Recruiting | Renal Disease Research Institute | Landry | Dallas, 75246, United States |
Withdrawn | DaVita Clinical Research | North Houston, TX | Shenandoah, 77384, United States |
Recruiting | Triad Internal Medicine | Asheboro, 27203-5573, United States |
Recruiting | Nova Clinical Research | Brandenton, FL | Brandenton, 34209, United States |
Withdrawn | DaVita Clinical Research | Westover Hills, San Antonio, TX | San Antonio, 78251, United States |
Recruiting | Renstar Medical Research | Ocala, 34470, United States |
Not yet recruiting | Elixia Central Florida | Orlando, 32608, United States |
Recruiting | Research by Design, LLC | Chicago, IL | Chicago, 60643, United States |
Recruiting | California Kidney Specialists - San Dimas | San Dimas, 91773, United States |
Not yet recruiting | Vanderbilt University Medical Center | Nashville, 37232, United States |
Recruiting | Salem VA Medical Center - Cardiology | Salem, 24153, United States |
Active, not recruiting | Southwest Houston Research, Ltd. | Houston, 77099, United States |
Recruiting | Chubu Rosai Hospital | Nagoya, 455-8530, Japan |
Not yet recruiting | Ehime Prefectural Central Hospital | Matsuyama, 790-0024, Japan |
Recruiting | Fukui Prefectural Hospital | Fukui-shi, 910-0846, Japan |
Withdrawn | JA Toride Medical Center | Toride, 302-0022, Japan |
Not yet recruiting | Japanese Red Cross Fukuoka Hospital | Fukuoka, 815-8555, Japan |
Recruiting | Japanese Red Cross Saitama Hospital | Saitama, 330-8553, Japan |
Recruiting | Jiyugaoka Yamada Internal Medicine Clinic | Obihiro, 080-0848, Japan |
Not yet recruiting | Juntendo University Urayasu Hospital | Urayasu, 279-0021, Japan |
Recruiting | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Not yet recruiting | Komatsu Municipal Hospital | Komatsu City, 923-8560, Japan |
Recruiting | Hirohata Naika Clinic | Kitakyushu, 807-0857, Japan |
Recruiting | Naka Kinen Clinic | Naka-shi, 311-0113, Japan |
Recruiting | Nara Prefecture General Medical Center | Nara, 630-8581, Japan |
Recruiting | Osaka General Medical Center | Osaka, 558-8558, Japan |
Recruiting | Saiseikai Matsuyama Hospital | Matsuyama, 791-8026, Japan |
Recruiting | Saiseikai Yokohamashi Nanbu Hospital | Yokohama, 234-0054, Japan |
Recruiting | Shonan Kamakura General Hospital | Kamakura, 247-8533, Japan |
Not yet recruiting | University of Yamanashi Hospital | Chuo, 409-3898, Japan |
Recruiting | Yokohama City University Hospital | Yokohama, 236-0004, Japan |
Recruiting | Katta General Hospital | Shiroishi, 989-0231, Japan |
Recruiting | Kasugai Municipal Hospital | Kasugai, 486-8510, Japan |
Not yet recruiting | NTT Medical Center Tokyo | Shinagawa-ku, 141-8625, Japan |
Not yet recruiting | Hamamatsu University Hospital | Hamamatsu, 431-3192, Japan |
Recruiting | Rinku General Medical Center | Izumisano, 598-0048, Japan |
Recruiting | Steel Memorial Yawata Hospital | Kitakyusyu, 805-8508, Japan |
Recruiting | Hospital Universitario Nuestra Senora de Valme | Internal Medicine Department | Sevilla, 41014, Spain |
Recruiting | Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition | A Coruna, 15006, Spain |
Recruiting | Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial | Ferrol, 15405, Spain |
Recruiting | Hospital Quironsalud Barcelona | Internal Medicine Department | Barcelona, 8023, Spain |
Recruiting | La Fe University and Polytechnic Hospital | Nephrology Department | Valencia, 46026, Spain |
Recruiting | Hospital Universitario Doctor Peset | Nephrology Department | Valencia, 46017, Spain |
Recruiting | Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna | Madrid, 28034, Spain |
Recruiting | Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department | Madrid, 28040, Spain |
Recruiting | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Nephrology Department | L'Hospitalet de Llobregat, 8907, Spain |
Recruiting | Hospital Clinico Universitario de Valencia | Nephrology Department | MISSING, 46010, Spain |
Not yet recruiting | Epicura / Nephrology | Baudour, 7331, Belgium |
Not yet recruiting | Jan Yperman Ziekenhuis / Nephrology | Ieper, 8900, Belgium |
Not yet recruiting | UZ Brussel Nephrology | Jette, 1090, Belgium |
Recruiting | Universitetssjukhuset i Linköping | LInköping, 581 85, Sweden |
Recruiting | Sahlgrenska Universitetssjukhuset - Njurkliniken | Gothenburg, 413 45, Sweden |
Recruiting | Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken | Uppsala, 751 85, Sweden |
Recruiting | Center For Diabetes, Academic Specialist Center | Stockholm, 113 65, Sweden |
Recruiting | ProbareE Stockholm | Stockholm, 113 29, Sweden |
Recruiting | Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos | Lisbon, 1250-189, Portugal |
Recruiting | Centro Privado San Vicente Diabetes | Córdoba, 5000, Argentina |
Not yet recruiting | Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Buenos Aires, C1431FWO, Argentina |
Recruiting | Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina | Temperley, B1834GUK, Argentina |
Recruiting | Biodial | Puchov, Slovakia | Puchov, 02001, Slovakia |
Recruiting | NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice | Kosice, 04011, Slovakia |
Recruiting | B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia | Galanta, 924 22, Slovakia |
Recruiting | B. Braun Avium Nefrologicka ambulancia | Sala, Slovakia | Sala, 92719, Slovakia |
Recruiting | MEDISPEKTRUM s.r.o. | Bratislava, 85101, Slovakia |
Recruiting | DIABEDA s.r.o. | Bratislava, 83106, Slovakia |
Not yet recruiting | Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia | Bratislava, 83101, Slovakia |
Recruiting | Univerzitna nemocnica Martin | Martin, 036 59, Slovakia |
Recruiting | Huai'an First People's Hospital, Nanjing Medical University | Huai'An, 223300, China |
Recruiting | The Second Affiliated Hospital of Nanjing Medical university | nanjing, 210000, China |
Recruiting | Jiangsu Province Hospital of Traditional Chinese Medicine (TCM) | Nanjing, 210029, China |
Recruiting | The Third Xiangya Hospital of Central South University | changsha, 410000, China |
Recruiting | Shanxi Bethune Hospital | Taiyuan, 030032, China |
Recruiting | The First Affiliated Hospital of Xiamen University | Xiamen, 361003, China |
Recruiting | Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH) | Beijing, 100029, China |
Recruiting | Huadong Hospital, Affiliated to Fudan University | Shanghai, 200040, China |
Recruiting | Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH) | Chengdu, 610072, China |
Recruiting | Sichuan University - West China Hospital | Chengdu, 610041, China |
Recruiting | Shandong Provincial Hospital | Jinan, 250021, China |
Recruiting | Peking University People's Hospital | Beijing, 100032, China |
Withdrawn | Shandong Provincial Hospital | Jinan, 250021, China |
Recruiting | Renji Hospital Shanghai JiaoTong University of Medicine | Shanghai, 200001, China |
Recruiting | The First Affiliated Hospital of Guangzhou University of TCM | Guangzhou, 510405, China |
Not yet recruiting | The Second Hospital of Jilin University | Changchun, 130000, China |
Withdrawn | Asan Medical Center | Seoul, 5505, Korea,_republic_of |
Withdrawn | Korea University Anam Hospital | Seoungbuk-gu, 02841, Korea,_republic_of |
Withdrawn | Samsung Medical Center | Seoul, 06351, Korea,_republic_of |
Withdrawn | Severance Hospital, Yonsei University Health System | Seoul, 3722, Korea,_republic_of |
Withdrawn | Korea University Ansan Hospital | Gyeonggi-do, 425-707, Korea,_republic_of |
Withdrawn | Yonsei University Wonju Christian Hospital | Wonju, 26426, Korea,_republic_of |
Withdrawn | Hallym University Sacred Heart Hospital | Anyang-si, 14068, Korea,_republic_of |
Withdrawn | Marengo Asia Hospital, Gurugram | Gurugram, 122011, India |
Recruiting | Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited) | New Delhi, 110017, India |
Recruiting | The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital) | Calcutta, 700020, India |
Recruiting | Mavani Research Center | Ahmedabad, 380052, India |
Recruiting | Life Care Clinic (LifeCare Clinic & Research Centre (LCRC)) | Bangalore, 560092, India |
Not yet recruiting | All India Institute of Medical Sciences (AIIMS) - New Delhi | New Delhi, 110 029, India |
Recruiting | Madras Diabetes Research Foundation | Chennai, 600 086, India |
Recruiting | Singapore General Hospital | Singapore, 169608, Singapore |
Withdrawn | Khoo Teck Puat Hospital | Singapore, 768828, Singapore |
Recruiting | Changi General Hospital | Singapore, 529889, Singapore |
Recruiting | National University Hospital Medical Centre | Singapore, 119074, Singapore |
Recruiting | Tan Tock Seng Hospital | Singapore, 308433, Singapore |
Recruiting | The First People's Hospital - Foshan | Foshan, 528000, China |
Not yet recruiting | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia, Dialisi e Trapianti di Rene | Milano, 20122, Italy |
Recruiting | Far Eastern Memorial Hospital | New Taipei, 220, Taiwan |
Not yet recruiting | Chi-Mei Medical Center, Liouyine | Tainan, 736, Taiwan |
Not yet recruiting | Chang Gung Memorial Hospital Kaohsiung | Kaohsiung, 833, Taiwan |
Recruiting | National Heart Centre Singapore | Singapore, 169609, Singapore |
Recruiting | Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica | Lisboa, 1500-650, Portugal |
Not yet recruiting | Changhua Christian Hospital | Changhua, 50006, Taiwan |
Not yet recruiting | National Taiwan University Hospital | Taipei, 100, Taiwan |
Not yet recruiting | Taizhou Hospital of Zhejiang Province | Taizhou, 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 UACRdate_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 interventiondate_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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
6