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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523425-17 | Registry Identifier | CTIS | |
| U1111-1328-7108 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.
Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.
Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary focal segmental glomerulosclerosis (sFSGS) cohort | Experimental |
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| Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort | Experimental |
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| Alport Syndrome cohort | Experimental |
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| Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort | Experimental |
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| Placebo cohort | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764198 | Drug | BI 764198 |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR) | At baseline and week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20 | At baseline and week 20 | |
| Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20 | At baseline and week 20 |
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Inclusion Criteria:
Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
Weight of ≥40 kg at screening
Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit
Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants <18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants <18)
Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator
If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)
Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period
Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.
Further inclusion criteria apply.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Consultants, LLC | Not yet recruiting | Huntsville | Alabama | 35805 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a 'Document Sharing Agreement'.
For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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basket trial
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| Placebo matching BI 764198 | Drug | Placebo matching BI 764198 |
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| Absolute change in estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20 | At baseline and week 20 |
| Kidney Disease Medical Group | Not yet recruiting | Glendale | California | 91206 | United States |
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| Amicis Research Center - Balboa | Not yet recruiting | Granada Hills | California | 91344 | United States |
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| Academic Medical Research Institute - Glendale | Not yet recruiting | Los Angeles | California | 90022 | United States |
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| University of California Los Angeles | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Colorado Kidney Care | Recruiting | Denver | Colorado | 80220 | United States |
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| Florida Kidney Physicians - Boca Raton | Not yet recruiting | Boca Raton | Florida | 33487 | United States |
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| Florida Kidney Physicians, LLC - Fort Lauderdale | Not yet recruiting | Fort Lauderdale | Florida | 33316 | United States |
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| Total Research Group, LLC | Recruiting | Miami | Florida | 33126 | United States |
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| CTR Oakwater, LLC | Not yet recruiting | Orlando | Florida | 32806 | United States |
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| Florida Kidney Physicians - Riverview/Brandon | Not yet recruiting | Riverview | Florida | 33578 | United States |
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| Ann & Robert H. Lurie Children's Hospital of Chicago | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| Endeavor Health | Not yet recruiting | Evanston | Illinois | 60201 | United States |
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| Johns Hopkins Hospital | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
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| St. Clair Nephrology Research, LLC - Shelby Township | Not yet recruiting | Shelby | Michigan | 48315 | United States |
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| New York Nephrology and Dialysis Access Surgery, PC | Not yet recruiting | Clifton Park | New York | 12065 | United States |
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| NYU Langone Nephrology Associates-Mineola | Not yet recruiting | Mineola | New York | 11501 | United States |
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| Duke University Medical Center | Not yet recruiting | Durham | North Carolina | 27710 | United States |
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| Cleveland Clinic | Not yet recruiting | Cleveland | Ohio | 44195 | United States |
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| Nationwide Children's Hospital | Not yet recruiting | Columbus | Ohio | 43205 | United States |
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| Northeast Clinical Research Center | Not yet recruiting | Bethlehem | Pennsylvania | 18017 | United States |
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| Southeast Renal Research Institute | Not yet recruiting | Chattanooga | Tennessee | 37404 | United States |
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| Nephrotex Research Group | Not yet recruiting | Dallas | Texas | 75231 | United States |
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| Provecta Researh Network | Not yet recruiting | Houston | Texas | 77027 | United States |
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| West Virginia University Medicine | Not yet recruiting | Morgantown | West Virginia | 26506 | United States |
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| Terapia Renal Domiciliaria | Not yet recruiting | Buenos Aires | 1407 | Argentina |
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| Centro Medico Dra Laura Maffei | Recruiting | Ciudad Autonoma Buenos Aires | C1425AGC | Argentina |
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| Clinica Privada Velez Sarfield | Not yet recruiting | Córdoba | 5000 | Argentina |
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| CardioAlem Investigaciones | Not yet recruiting | San Isidro | B1642DCD | Argentina |
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| Nepean Hospital | Not yet recruiting | Kingswood | New South Wales | 2747 | Australia |
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| John Hunter Hospital | Not yet recruiting | New Lambton Heights | New South Wales | 2305 | Australia |
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| Royal Brisbane and Women's Hospital | Not yet recruiting | Brisbane | Queensland | 4029 | Australia |
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| Princess Alexandra Hospital | Not yet recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| AZORG Ziekenhuis | Not yet recruiting | Aalst | 9300 | Belgium |
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| Hopital Erasme | Not yet recruiting | Brussels | 1070 | Belgium |
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| Az Maria Middelares Gent | Not yet recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
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| Universidade Federal do Ceara | Recruiting | Fortaleza | 60110-110 | Brazil |
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| Hospital de Clinicas de Porto Alegre | Not yet recruiting | Porto Alegre | 90035-903 | Brazil |
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| Fundacao Oswaldo Ramos (Hospital do Rim) | Recruiting | São Paulo | 04038-002 | Brazil |
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| Hospital das Clínicas da Faculdade de Medicina da USP | Not yet recruiting | São Paulo | 05403-000 | Brazil |
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| Instituto da Crianca e do Adolescente | Not yet recruiting | São Paulo | 05403-901 | Brazil |
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| CaRe Clinic (Calgary) | Not yet recruiting | Calgary | Alberta | T2N 4L7 | Canada |
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| Victoria Hospital (LHSC) | Not yet recruiting | London | Ontario | N6A 5W9 | Canada |
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| Maisonneuve-Rosemont Hospital | Not yet recruiting | Monteral | Quebec | H1T 2M4 | Canada |
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| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
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| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | 100044 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | 610041 | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | 510080 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | 330006 | China |
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| Zhongda Hospital Southeast University | Not yet recruiting | Nanjing | 210009 | China |
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| The First People's Hospital of Nanning | Recruiting | Nanning | 530000 | China |
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| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | 200025 | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | 200080 | China |
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| People's Hospital of Sichuan Province | Not yet recruiting | Sichuan | 610031 | China |
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| Renmin Hospital of Wuhan University | Not yet recruiting | Wuhan | 430060 | China |
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| Zhongshan Hospital Affiliated to Xiamen University | Not yet recruiting | Xiamen | 361004 | China |
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| Specijalna Bolnica Medico | Not yet recruiting | Rijeka | 51000 | Croatia |
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| General Hospital Vinkovci | Not yet recruiting | Vinkovci | 32100 | Croatia |
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| Clinical Hospital Sveti Duh | Not yet recruiting | Zagreb | 10000 | Croatia |
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| Solmed Polyclinic | Not yet recruiting | Zagreb | 10000 | Croatia |
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| University Hospital Dubrava | Not yet recruiting | Zagreb | 10000 | Croatia |
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| Zealand University Hospita; Roskilde | Not yet recruiting | Roskilde | 4000 | Denmark |
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| Tartu University Hospital | Not yet recruiting | Tartu | 50406 | Estonia |
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| CHU Amiens-Picardie | Not yet recruiting | Amiens | 80054 | France |
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| HOP Pellegrin | Not yet recruiting | Bordeaux | 33076 | France |
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| Hopital Henri Mondor | Not yet recruiting | Créteil | 94000 | France |
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| Hopital Pasteur | Recruiting | Nice | 06000 | France |
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| Hopital Necker | Not yet recruiting | Paris | 75015 | France |
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| Vivantes Klinikum im Friedrichshain | Not yet recruiting | Berlin | 10249 | Germany |
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| Universitätsklinikum Köln (AöR) | Not yet recruiting | Cologne | 50937 | Germany |
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| Universitätsklinikum Hamburg, Eppendorf | Not yet recruiting | Hamburg | 20246 | Germany |
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| Medizinische Hochschule Hannover | Not yet recruiting | Hanover | 30625 | Germany |
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| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Not yet recruiting | Mainz | 55131 | Germany |
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| Klinikum rechts der Isar der Technischen Universität München | Not yet recruiting | München | 81675 | Germany |
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| University General Hospital of Heraklion | Not yet recruiting | Heraklion | 71500 | Greece |
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| General University Hospital of Patras | Not yet recruiting | Pátrai | 265 04 | Greece |
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| Aartham Multi Super Speciality Hospital | Not yet recruiting | Ahmedabad | 380015 | India |
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| AIIMS Bhubaneshwar | Not yet recruiting | Bhubaneswar | 751019 | India |
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| Osmania Medical College & Hospital | Not yet recruiting | Hyderabad | 500012 | India |
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| Nizam's Institute of Medical Sciences | Not yet recruiting | Hyderabad | 500082 | India |
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| Government Medical College | Not yet recruiting | Kozhikode | 673008 | India |
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| Sanjay Gandhi Post Graduate Inst. of Medical Sciences | Not yet recruiting | Lucknow | 226014 | India |
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| JSS Medical College | Not yet recruiting | Mysore | 570015 | India |
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| Noble Hospital Pvt Ltd | Not yet recruiting | Pune | 411013 | India |
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| Galaxy Lifecare Services Pvt. Ltd. | Not yet recruiting | Varanasi | 201010 | India |
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| Azienda Ospedaliero Universitaria delle Marche | Not yet recruiting | Ancona | 60126 | Italy |
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| Azienda Universitaria Ospedaliera Consorziale Policlinico Bari | Not yet recruiting | Bari | 70124 | Italy |
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| Policlinico S. Orsola-Malpighi | Not yet recruiting | Bologna | 40138 | Italy |
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| A.O.U.Policlinico G.Martino | Not yet recruiting | Messina | 98124 | Italy |
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| Asst Santi Paolo E Carlo | Not yet recruiting | Milan | 20142 | Italy |
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| Fondazione Salvatore Maugeri | Not yet recruiting | Pavia | 27100 | Italy |
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| IRCCS Ospedale "Casa Sollievo della Sofferenza" | Not yet recruiting | San Giovanni Rotondo (FG) | 71013 | Italy |
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| Azienda Ospedaliera Universitaria Integrata Verona | Not yet recruiting | Verona | 37126 | Italy |
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| Kasugai Municipal Hospital | Not yet recruiting | Aichi, Kasugai | 486-8510 | Japan |
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| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Recruiting | Aichi, Nagoya | 466-8650 | Japan |
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| Japanese Red Cross Fukuoka Hospital | Not yet recruiting | Fukuoka, Fukuoka | 815-8555 | Japan |
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| Kobe University Hospital | Not yet recruiting | Hyogo, Kobe | 650-0017 | Japan |
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| The Jikei University Hospital | Not yet recruiting | Tokyo, Minato-ku | 105-8471 | Japan |
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| Tokyo Women's Medical University Hospital | Not yet recruiting | Tokyo, Shinjuku-ku | 162-8666 | Japan |
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| Hospital Selayang | Not yet recruiting | Batu Caves | 68100 | Malaysia |
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| Hospital Sultan Idris Shah Serdang | Not yet recruiting | Kajang | 43000 | Malaysia |
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| Sunway Medical Centre | Not yet recruiting | Selangor Darul Ehsan | 47500 | Malaysia |
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| Centenario Hospital Miguel Hidalgo | Not yet recruiting | Aguascalientes | 20259 | Mexico |
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| Health Pharma Professional Research S.A. de C.V. | Not yet recruiting | Mexico City | 03100 | Mexico |
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| Soltmed Smo | Not yet recruiting | Mexico City | 03650 | Mexico |
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| Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran | Not yet recruiting | Mexico City | 14080 | Mexico |
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| Servicios de Oncología Medica Integral, S.A de C.V. Sucursal Renal | Not yet recruiting | Monterrey | 64060 | Mexico |
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| Instituto Nacional de Cardiologia Ignacio Chavez | Not yet recruiting | Tlalpan | 14080 | Mexico |
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| Amsterdam UMC Locatie AMC | Not yet recruiting | Amsterdam | 1105 AZ | Netherlands |
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| Universitair Medisch Centrum Groningen | Not yet recruiting | Groningen | 9713 GZ | Netherlands |
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| Pacific Clinical Research Network - Auckland | Not yet recruiting | Auckland | 622 | New Zealand |
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| Waikato Hospital | Not yet recruiting | Hamilton | 3204 | New Zealand |
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| Akershus Universitetssykehus HF | Not yet recruiting | Lørenskog | 1478 | Norway |
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| Oslo Universitetssykehus HF, Ulleval sykehus | Not yet recruiting | Oslo | 0450 | Norway |
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| Helse Stavanger, Stavanger Universitetssykehus | Not yet recruiting | Stavanger | N-4011 | Norway |
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| Universitetssykehuset Nord-Norge, Tromso | Not yet recruiting | Tromsø | 9019 | Norway |
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| Central Clinical Hospital of the Medical University of Lodz | Not yet recruiting | Lodz | 92-213 | Poland |
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| Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu | Not yet recruiting | Poznan | 60-355 | Poland |
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| Uniwersytecki Szpital Kliniczny Nr 2 Pum W Szczecinie | Not yet recruiting | Szczecin | 70-111 | Poland |
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| Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W Warszawie | Not yet recruiting | Warsaw | 02-091 | Poland |
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| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy | Not yet recruiting | Warsaw | 04-141 | Poland |
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| Unidade Local de Saúde de Almada-Seixal E.P.E. | Not yet recruiting | Almada | 2805-267 | Portugal |
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| ULS Braga | Not yet recruiting | Braga | 4710-243 | Portugal |
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| ULS de Santa Maria, E.P.E | Not yet recruiting | Lisbon | 1649-035 | Portugal |
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| Unidade Local de Saúde Lisboa Occidental, E.P.E | Not yet recruiting | Lisbon | 2790-134 | Portugal |
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| ULS de Loures-Odivelas, E.P.E | Not yet recruiting | Loures | 2674-514 | Portugal |
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| Institutul Clinic Fundeni | Not yet recruiting | Bucharest | 022328 | Romania |
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| County Emergency Hospital "Pius Brinzeu" Timisoara | Not yet recruiting | Timișoara | 300723 | Romania |
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| Singapore General Hospital | Recruiting | Singapore | 169608 | Singapore |
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| Tan Tock Seng Hospital | Not yet recruiting | Singapore | 308433 | Singapore |
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| F D Roosevelt University General Hospital Of Banska Bystrica | Not yet recruiting | Banská Bystrica | 975 17 | Slovakia |
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| University Hospital and Comenius University in Bratislava, Derer´s Hospital | Not yet recruiting | Bratislava | 833 05 | Slovakia |
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| Univerzitna nemocnica L. Pasteura Kosice | Not yet recruiting | Košice | 04011 | Slovakia |
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| FMC Dialysis Services Kosice | Not yet recruiting | Košice | 40190 | Slovakia |
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| Univ. Hospital Martin | Not yet recruiting | Martin | 036 01 | Slovakia |
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| Kyung Hee University Hospital at Gangdong | Not yet recruiting | Seoul | 05278 | South Korea |
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| Ajou University Hospital | Not yet recruiting | Suwon | 16499 | South Korea |
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| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
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| Hospital Sant Joan de Déu | Not yet recruiting | Esplugues de Llobregat | 08950 | Spain |
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| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Clinico De Valencia (INCLIVA) | Not yet recruiting | Valencia | 46010 | Spain |
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| Danderyds Sjukhus | Not yet recruiting | Danderyd | 182 88 | Sweden |
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| Universitetssjukhuset, Linköping | Not yet recruiting | Linköping | 581 85 | Sweden |
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| Uppsala University Hospital | Not yet recruiting | Uppsala | 751 85 | Sweden |
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| Klinik Hirslanden | Not yet recruiting | Zurich | 8032 | Switzerland |
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| Taipei Medical University-Shuang Ho Hospital | Recruiting | New Taipei City | 235 | Taiwan |
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| China Medical University Hospital | Not yet recruiting | Taichung | 40447 | Taiwan |
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| Taichung Veterans General Hospital | Not yet recruiting | Taichung | 40705 | Taiwan |
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| National Taiwan University Hospital | Recruiting | Taipei | 100225 | Taiwan |
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| Adana City Hospital | Not yet recruiting | Adana | 01220 | Turkey (Türkiye) |
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| Ankara Etlik City Hospital | Not yet recruiting | Ankara | 06200 | Turkey (Türkiye) |
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| Bursa Uludag University | Not yet recruiting | Bursa | 16110 | Turkey (Türkiye) |
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| Istanbul Capa University | Not yet recruiting | Istanbul | 34093 | Turkey (Türkiye) |
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| Kocaeli University Faculty of Medicine Hospital | Not yet recruiting | İzmit | 41000 | Turkey (Türkiye) |
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| Erciyes University | Not yet recruiting | Melikgazi/Kayseri | 38039 | Turkey (Türkiye) |
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| Bradford Institute for Health Research | Recruiting | Bradford | BD9 6RJ | United Kingdom |
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| The Royal London Hospital | Recruiting | London | E1 1BB | United Kingdom |
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| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
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| Salford Royal | Not yet recruiting | Salford | M6 8HD | United Kingdom |
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