New pill aims to protect kidneys by cutting protein loss
NCT ID NCT06522997
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new drug called BAY 3283142 in 1222 adults with chronic kidney disease and high protein in their urine. Participants took either the drug or a placebo on top of their usual treatments for 16 weeks. The goal was to see if the drug could lower urine albumin levels, a key sign of kidney damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAY 3283142
- What this could lead to
- If successful, this could lead to a new add-on treatment to slow kidney damage in people with chronic kidney disease.
- What could go wrong
- This is a mid-stage trial with 1222 participants, so results are not yet definitive. The drug may not reduce albuminuria significantly or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
1,222 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Papa Giovanni XXIII | Ospedale di Bergamo - SC Malattie Endocrine-Diabetologia
Bergamo, 24127, Italy
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AZ Delta / Nephrology
Roeselare, 8800, Belgium
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Akademiska sjukhuset (Uppsala University Hospital) - Njurkliniken
Uppsala, Uppsala County, 751 85, Sweden
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All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, National Capital Territory of Delhi, 110029, India
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Area Sanitaria De Ferrol | Medicina Interna
Ferrol, A Coruña, 15405, Spain
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Associacao Protectora dos Diabeticos de Portugal | Departamento de Ensaios Clinicos
Lisbon, 1250-189, Portugal
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Azienda Ospedaliera Universitaria Gaetano Martino Messina - Nefrologia e Dialisi
Messina, 98124, Italy
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Azienda Ospedaliero Universitaria di Modena_Policlinico - Nefrologia, Dialisi e Trapianto di Rene
Modena, 41124, Italy
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Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto
Bologna, Emilia-Romagna, 40138, Italy
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B. Braun Avitum Nefrologicka Ambulancia | Galanta, Slovakia
Galanta, 924 22, Slovakia
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B. Braun Avitum Nefrologicka ambulancia | Sala, Slovakia
Šaľa, 92719, Slovakia
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BIODIAL spol. s r.o.
Púchov, 02001, Slovakia
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Balboa Research SMO+ - Chula Vista
Chula Vista, California, 91910, United States
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Barts Health NHS Trust - Royal London Hospital - Nephrology
London, Greater London, E1 1FR, United Kingdom
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Bellvitge Hospital Universitari | Nefrologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
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CEDIC Centro de Investigación Clínica | Buenos Aires, Argentina
CABA, Ciudad Auton. de Buenos Aires, C1018DES, Argentina
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California Kidney Specialists - San Dimas
San Dimas, California, 91773, United States
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Capital Medical University (CMU) - Beijing Anzhen Hospital (BAH)
Beijing, 100029, China
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Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, Wales, CF14 4XW, United Kingdom
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Center For Diabetes, Academic Specialist Center
Stockholm, Stockholm County, 113 65, Sweden
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Centro Clinico Academico Braga | Braga, Portugal
Braga, 4710-243, Portugal
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Centro Hospitalar Universitario de Lisboa Central | Hospital Curry Cabral - Nephrology Department
Lisbon, 1069-166, Portugal
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Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department
Torres Novas, Santarém District, 2350-754, Portugal
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Centro Privado San Vicente Diabetes
Córdoba, 5000, Argentina
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Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
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Centro de Especialidades Medicas (Cemedic) | Cardiology Department
Villa Luro, Ciudad Auton. de Buenos Aires, C1440CFD, Argentina
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Centro de Investigaciones Medicas Temperley | Buenos Aires, Argentina
Temperley, Buenos Aires, B1834GUK, Argentina
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Centro de Investigaciones Metabolicas | Ciudad de Autonoma de Buenos Aires, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Aires, C1056ABI, Argentina
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Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, San Luis Province, D5700CGR, Argentina
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Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833, Taiwan
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Changhua Christian Hospital
Changhua, Changhua, 50006, Taiwan
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Changi General Hospital
Singapore, 529889, Singapore
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Chi-Mei Medical Center, Liouyine
Tainan, 73657, Taiwan
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Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530, Japan
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Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
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Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
A Coruña, 15006, Spain
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DIAB s.r.o
Rožňava, 048 01, Slovakia
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DIABEDA s.r.o.
Bratislava, 83106, Slovakia
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Eastern Nephrology Associates - New Bern
New Bern, North Carolina, 28562, United States
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Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
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Elixia Central Florida
Orlando, Florida, 32608, United States
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Epicura / Nephrology
Baudour, 7331, Belgium
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Epsom and St Helier University Hospitals NHS Trust | St Helier Hospital - Clinical Trials Unit
Carshalton, Surrey, SM5 1AA, United Kingdom
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Far Eastern Memorial Hospital
New Taipei City, New Taipei, 220, Taiwan
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Florida Institue for Clinical Research
Orlando, Florida, 32825, United States
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Fukui Prefectural Hospital
Fukui-shi, Fukui, 910-0846, Japan
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Fundacion Centro de Salud e Investigaciones Medicas | Santa Rosa, Argentina
Santa Rosa, 0, Argentina
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General Hospital Of Thessaloniki Papageorgiou-Renal Department
Efkarpia, Thessaloniki, 56429, Greece
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General University Hospital Of Larissa-Nephrology Clinic
Larissa, 41100, Greece
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Geniko Nosokomeio Thessalonikis George Papanikolaou-Nephrology Department
Thessaloniki, 57010, Greece
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Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
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Hirohata Naika Clinic
Kitakyushu, Fukuoka, 807-0857, Japan
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Hospital Clinico Universitario De Valencia | Nefrologia
Valencia, 46010, Spain
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Hospital Pedro Hispano | Clinical Research Center
Matosinhos Municipality, Porto District, 4464-513, Portugal
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Hospital Quironsalud Barcelona | Internal Medicine Department
Barcelona, 8023, Spain
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Hospital Universitario Dr Peset Aleixandre | Nefrologia
Valencia, 46017, Spain
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Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
Madrid, 28040, Spain
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Hospital Universitario Ramon Y Cajal | Medicina Interna
Madrid, 28034, Spain
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Hospital Universitario Virgen De Valme | Medicina Interna
Seville, 41014, Spain
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Hospital Universitario Y Politecnico La Fe | Nefrologia
Valencia, 46026, Spain
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Huadong Hospital, Affiliated to Fudan University
Shanghai, 200040, China
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Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300, China
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Hull University Teaching Hospitals NHS Trust | Hull Royal Infirmary - Academic Renal Research Department
Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom
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Ippokratio General Hospital Of Thessaloniki- 1st Department of Nephrology
Thessaloniki, 54642, Greece
-
Istituti Clinici Scientifici Maugeri S.p.A._Pavia - Nefrologia
Pavia, 27100, Italy
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Jan Yperman Ziekenhuis / Nephrology
Ieper, 8900, Belgium
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Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555, Japan
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Japanese Red Cross Saitama Hospital
Saitama, 330-8553, Japan
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Jiangsu Province Hospital of Traditional Chinese Medicine (TCM)
Nanjing, 210029, China
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Jiyugaoka Yamada Internal Medicine Clinic
Obihiro, Hokkaido, 080-0848, Japan
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Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
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Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510, Japan
-
Katta General Hospital
Shiroishi, Miyagi, 989-0231, Japan
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King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
London, Greater London, SE5 9RJ, United Kingdom
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Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
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Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
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Komatsu Municipal Hospital
Komatsu, Ishikawa-ken, 923-8560, Japan
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Laiko General Hospital Of Athens_ Department of Nephrology and Renal Transplantation
Athens, 11525, Greece
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Lakeside Healthcare | Lakeside Surgery - Research Department
Corby, Northamptonshire, NN17 2UR, United Kingdom
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Life Care Clinic (LifeCare Clinic & Research Centre (LCRC))
Bengaluru, Karnataka, 560092, India
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Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650, Portugal
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MEDISPEKTRUM s.r.o.
Bratislava, 85101, Slovakia
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Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
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Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
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Manchester University NHS Foundation Trust | Manchester Royal Infirmary - Renal Care
Manchester, Greater Manchester, M13 9WL, United Kingdom
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Mavani Research Center
Ahmedabad, Gujarat, 380052, India
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Max Super Speciality Hospital, Saket (West Block), (A unit of Max Healthcare Institute Limited)
New Delhi, National Capital Territory of Delhi, 110017, India
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Mendez Center For Clinical Research | Woodbridge, VA
Woodbridge, Virginia, 22192, United States
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NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
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Naka Kinen Clinic
Naka, Ibaraki, 311-0113, Japan
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Nara Prefecture General Medical Center
Nara, 630-8581, Japan
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National Heart Centre Singapore
Singapore, 169609, Singapore
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National Taiwan University Hospital
Taipei, 100, Taiwan
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National University Hospital Medical Centre
Singapore, 119074, Singapore
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Nemocnica Akademika L. Derera - UNB, Nefrologicka ambulancia
Bratislava, 83101, Slovakia
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NephroCare | FMC-dialyzacne sluzby s.r.o. - Kosice
Košice, 04011, Slovakia
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Nephrology Associates of Northern Illinois and Indiana - Hinsdale
Hinsdale, Illinois, 60521, United States
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Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
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Northern Care Alliance NHS Foundation Trust | Salford Royal Hospital - Nephrology
Salford, Greater Manchester, M6 8HD, United Kingdom
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Nova Clinical Research - Blake Medical Center
Bradenton, Florida, 34209, United States
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Osaka General Medical Center
Osaka, 558-8558, Japan
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Peking University People's Hospital
Beijing, 100044, China
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Peninsula Kidney Associates - Hampton
Hampton, Virginia, 23666, United States
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ProbareE Stockholm
Stockholm, Stockholm County, 113 29, Sweden
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Renal Disease Research Institute | Landry
Dallas, Texas, 75246, United States
-
Renji Hospital Shanghai JiaoTong University of Medicine
Shanghai, 200001, China
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Renstar Medical Research - Deerwood Clinic
Ocala, Florida, 34471, United States
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Research by Design, LLC | Chicago, IL
Chicago, Illinois, 60643, United States
-
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
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Sahlgrenska Universitetssjukhuset - Njurkliniken
Gothenburg, Västra Götaland County, 413 45, Sweden
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Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026, Japan
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Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, 234-0054, Japan
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Salem VA Medical Center - Nephrology
Salem, Virginia, 24153, United States
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Shandong Provincial Hospital
Jinan, Shandong, 250021, China
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Shanxi Bethune Hospital
Taiyuan, 030032, China
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Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
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Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
Chengdu, 610072, China
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Sichuan University - West China Hospital
Chengdu, 610041, China
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SingHealth Polyclinics - Pasir Ris
Singapore, 519457, Singapore
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Singapore General Hospital
Singapore, 169608, Singapore
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Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30904, United States
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Southern Medical University - Nanfang Hospital (Southern Hospital)
Guangzhou, 510515, China
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Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
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Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508, Japan
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Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
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Tan Tock Seng Hospital
Singapore, 308433, Singapore
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The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
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The First People's Hospital - Foshan
Foshan, 528000, China
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The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital)
Kolkata, West Bengal, 700020, India
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The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, 210011, China
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The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
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Triad Internal Medicine - Asheboro
Asheboro, North Carolina, 27203, United States
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UZ Brussel Nephrology
Jette, 1090, Belgium
-
UZ Gent / Nephrology
Ghent, 9000, Belgium
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UZ Leuven / Nephrology
Leuven, 3000, Belgium
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Unidade Local De Saúde De Lisboa Ocidental E.P.E.
Carnaxide, Lisbon District, 2790-134, Portugal
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Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
Almada, Setúbal District, 2805-267, Portugal
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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, Portugal
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Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Nefrologia
Coimbra, 3000-075, Portugal
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Universitetssjukhuset i Linköping
Linköping, Östergötland County, 581 85, Sweden
-
University General Hospital Of Ioannina-Nephrology Clinic
Ioannina, 45500, Greece
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University General Hospital of Heraklion-Nephrology Clinic
Heraklion, 71500, Greece
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University General Hospital of Patras | Nephrology Clinic
Pátrai, Achaia, 26504, Greece
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University Hospitals Birmingham NHS Foundation Trust | Queen Elizabeth Hospital Birmingham - Clinical Research Facility
Birmingham, West Midlands, B15 2TH, United Kingdom
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University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
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Univerzitná nemocnica Martin (UNM) - Transplantacno-nefrologické oddelenie
Martin, 036 59, Slovakia
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Utah Kidney Research Institute | Salt Lake City, UT
South Salt Lake, Utah, 84115, United States
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Vanderbilt University Medical Center - Nephrology Clinical Trials Center
Nashville, Tennessee, 37232, United States
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Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510, United States
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Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
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