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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512577-27-00 | Registry Identifier | CTIS | |
| U1111-1312-1389 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD.
Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.
Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin treatment arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g] | Up to week 24 | |
| Change from Day 1 to the Week 24 visit in urine glucose [mmol/L] | Up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin | U25Crea = estimates the glomerular filtration rate based on creatinine in patients aged up to 25 years | Up to week 73 |
| Annual rate of change in eGFR (U25Crea) from the Week 8 to the Week 24 visit, including treatment effect extrapolation from (adult) EMPA-KIDNEY data |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Not yet recruiting | Birmingham | Alabama | 35233 | 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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| Placebo | Drug | Placebo |
|
| Up to week 24 |
| Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR) | Up to week 24 |
| The observed predose plasma concentrations of empagliflozin at the Week 26 visit | Up to week 26 |
| Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP) | SAE= serious adverse event AE= adverse event | Up to week 73 |
| Phoenix Children's Hospital | Not yet recruiting | Phoenix | Arizona | 85016 | United States |
|
| University of California Los Angeles | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Stanford University School of Medicine | Not yet recruiting | Palo Alto | California | 94304 | United States |
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| University of California Davis | Not yet recruiting | Sacramento | California | 95817 | United States |
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| University of California San Francisco | Not yet recruiting | San Francisco | California | 94158 | United States |
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| University of Miami | Not yet recruiting | Miami | Florida | 33136 | United States |
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| Emory University | Not yet recruiting | Atlanta | Georgia | 30322 | 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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| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Novak Center for Children's Health | Not yet recruiting | Louisville | Kentucky | 40202 | United States |
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| Johns Hopkins Hospital | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
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| Boston Children's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Children's Hospital of Michigan | Not yet recruiting | Detroit | Michigan | 48201 | United States |
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| M Health Fairview Masonic Children's Hospital | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| Children's Mercy Hospitals and Clinics | Not yet recruiting | Kansas City | Missouri | 64108 | United States |
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| Hackensack Meridian Health | Not yet recruiting | Hackensack | New Jersey | 07601 | United States |
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| Jersey Shore University Medical Center | Not yet recruiting | Neptune City | New Jersey | 07753 | United States |
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| University of New Mexico | Not yet recruiting | Albuquerque | New Mexico | 87131 | United States |
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| Cincinnati Children's Hospital Medical Center | Not yet recruiting | Cincinnati | Ohio | 45229 | 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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| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Texas Southwestern Medical Center | Not yet recruiting | Dallas | Texas | 75235 | United States |
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| Primary Children's Hospital | Not yet recruiting | Salt Lake City | Utah | 84113 | United States |
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| Virginia Commonwealth University Health Systems | Not yet recruiting | Richmond | Virginia | 23219 | United States |
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| Seattle Children's Hospital | Not yet recruiting | Seattle | Washington | 98105 | United States |
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| University of Wisconsin | Not yet recruiting | Madison | Wisconsin | 53705-9123 | United States |
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| Hospital Italiano de Buenos Aires | Not yet recruiting | CABA | C1199ABB | Argentina |
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| Hospital de Niños Dr. Ricardo Gutierrez | Not yet recruiting | CABA | C1425EFD | Argentina |
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| Equipo Ciencia | Recruiting | CABA | C1428BNF | Argentina |
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| The Children's Hospital at Westmead | Not yet recruiting | Westmead | New South Wales | 2145 | Australia |
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| Queensland Children's Hospital | Recruiting | South Brisbane | Queensland | 4101 | Australia |
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| Monash Children's Hospital | Not yet recruiting | Clayton | Victoria | 3168 | Australia |
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| The Royal Children's Hospital | Not yet recruiting | Parkville | Victoria | 3052 | Australia |
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| HUB CHU Brugmann | Not yet recruiting | Brussels | 1020 | Belgium |
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| Cliniques Universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| Universitair Ziekenhuis Gent | Not yet recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| CHC Mont Légia | Not yet recruiting | Liège | 4000 | Belgium |
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| University of Alberta Hospital (University of Alberta) | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| BC Children's Hospital | Not yet recruiting | Vancouver | British Columbia | V6H 3N1 | Canada |
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| The Hospital for Sick Children | Not yet recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| McGill University Health Centre (MUHC) | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| Jim Pattison Children's Hospital | Recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| Hôpital Louis Pradel | Recruiting | Bron | 69500 | France |
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| HOP Timone | Recruiting | Marseille | 13005 | France |
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| HOP Enfants et Adolescents | Not yet recruiting | Nantes | 44093 | France |
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| HOP Armand-Trousseau | Recruiting | Paris | 75012 | France |
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| Hopital Necker | Not yet recruiting | Paris | 75015 | France |
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| HOP des Enfants | Not yet recruiting | Toulouse | 31059 | France |
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| Universitätsklinikum Köln (AöR) | Not yet recruiting | Cologne | 50937 | Germany |
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| Universitätsklinikum Hamburg, Eppendorf | Recruiting | Hamburg | 20246 | Germany |
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| Universitätsklinikum Heidelberg | Not yet recruiting | Heidelberg | 69120 | Germany |
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| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
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| Semmelweis University, Faculty of Medicine | Not yet recruiting | Budapest | 1083 | Hungary |
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| University of Debrecen Clinical Centre | Not yet recruiting | Debrecen | 4032 | Hungary |
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| University of Pecs | Recruiting | Pécs | 7623 | Hungary |
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| Istituto G. Gaslini | Recruiting | Genova | 16147 | Italy |
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| Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico | Not yet recruiting | Milan | 20122 | Italy |
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| Azienda Ospedaliera Universitaria di Padova | Recruiting | Padova | 35128 | Italy |
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| Ospedale Pediatrico Bambino Gesù | Recruiting | Roma | 00165 | Italy |
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| Amsterdam University Medical Center | Recruiting | Amsterdam | 1105 AZ | Netherlands |
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| Universitair Medisch Centrum Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
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| Radboud Universitair Medisch Centrum | Not yet recruiting | Nijmegen | 6525 GA | Netherlands |
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| Erasmus Medisch Centrum | Recruiting | Rotterdam | 3015 GD | Netherlands |
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| UMC Utrecht | Not yet recruiting | Utrecht | 3584 CX | Netherlands |
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| Uniwersyteckie Centrum Kliniczne | Not yet recruiting | Gdansk | 80-211 | Poland |
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| University Children's Hospital in Lublin | Not yet recruiting | Lublin | 20-093 | Poland |
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| Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu | Recruiting | Torun | 87-100 | Poland |
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| The Children's Memorial Health Institute | Not yet recruiting | Warsaw | 04730 | Poland |
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| University Clinical Hospital in Wrocław | Not yet recruiting | Wroclaw | 50 556 | Poland |
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| CHUC - Centro Hospitalar e Universitario de Coimbra, EPE | Recruiting | Coimbra | 3000-602 | Portugal |
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| ULS de São José, E.P.E. - Hospital Dona Estefânia | Not yet recruiting | Lisbon | 1169-045 | Portugal |
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| ULS de Santa Maria, E.P.E | Not yet recruiting | Lisbon | 1600-190 | Portugal |
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| CHUP, EPE - Centro Materno Infantil do Norte | Recruiting | Porto | 4050-651 | Portugal |
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| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
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| KK Women's and Children's Hospital | Recruiting | Singapore | 229899 | Singapore |
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| Kyungpook National University Hospital | Recruiting | Daegu | 41944 | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | 61469 | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario de Cruces | Recruiting | Bilbao | 48903 | Spain |
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| Hospital Regional Universitario de Málaga | Not yet recruiting | Málaga | 29011 | Spain |
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| Hospital Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| Sahlgrenska Universitetssjukhuset, Östra | Not yet recruiting | Gothenburg | 416 85 | Sweden |
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| Karolinska University Hospital | Recruiting | Stockholm | 141 86 | Sweden |
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| Hacettepe University | Not yet recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| Ankara Universitesi Tip Fakultesi | Not yet recruiting | Ankara | 06620 | Turkey (Türkiye) |
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| Istanbul Capa University | Not yet recruiting | Istanbul | 34093 | Turkey (Türkiye) |
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| Osmangazi University | Not yet recruiting | Odunpazari | 26040 | Turkey (Türkiye) |
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| Birmingham Children's Hospital | Recruiting | Birmingham | B4 6NH | United Kingdom |
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| Bristol Royal Hospital for Children | Recruiting | Bristol | BS2 8BJ | United Kingdom |
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| Queen Elizabeth University Hospital | Recruiting | Glasgow | G51 4TF | United Kingdom |
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| Alder Hey Children's Hospital | Recruiting | Liverpool | L12 2AP | United Kingdom |
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| Great Ormond Street Hospital | Recruiting | London | WC1N 3JH | United Kingdom |
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| Great North Children's Hospital | Not yet recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
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| Nottingham Children's Hospital | Not yet recruiting | Nottingham | NG7 2UH | United Kingdom |
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| NIHR Southampton Clinical Research Facility | Recruiting | Southampton | SO16 6YD | United Kingdom |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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