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Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5). These genes help in producing an important protein called collagen. People with AS have a high risk of developing chronic kidney disease (CKD), a condition in which there is progressive loss in kidney function over time. The kidneys soon lose their ability to remove waste products from the body properly, resulting in end-stage kidney disease. A common sign of decreasing kidney function is the presence of excess protein in the urine that is not usually found with healthy kidneys. This condition is known as proteinuria. The study drug, BAY 3401016 (a monoclonal antibody), is a type of medicine that blocks a protein called Semaphorin 3A (Sema3A), which is thought to be involved in causing kidney damage in AS. By blocking the action of the Sema3A protein, BAY 3401016 may prevent proteinuria and slow down the loss in kidney function due to AS.
The main purpose of this study is to learn more about how well BAY 3401016 works in slowing down the loss in kidney function in adults with a rapidly progressing AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY 3401016 | Experimental | BAY 3401016 weekly for 24 weeks in addition to background therapy if eligible |
|
| Placebo | Placebo Comparator | Placebo weekly for 24 weeks in addition to background therapy if eligible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 3401016 | Biological | BAY 3401016 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary albumin creatinine ratio (UACR) ratio to baseline averaged over 16, 20 and 24 weeks of treatment | Progression of kidney disease, including Alport Syndrome (AS), to End-Stage Renal Disease (ESRD) takes years, making it challenging to establish drug efficacy in clinical trials without long follow-ups or large sample sizes. Using surrogate endpoints, such as early changes in albuminuria, can help address this issue. It is tested wether BAY 3401016 has an effect on albuminuria in AS patients. Research shows that albumin overload leads to renal function decline and podocyte injury. | From the start of study intervention, over 16, 20 and 24 weeks of treatment, until the last follow-up visit, 90 days ± 3 days after EoT |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the safety and tolerability of BAY 3401016 in participants with AS | Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the start of study intervention until the last follow-up visit, 90 days ± 3 days after EoT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Clinic at The Kirklin Clinic of UAB Hospital | Recruiting | Birmingham | Alabama | 35233 | United States | |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Two parallel groups (BAY 3401016 and placebo)
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| Other |
Placebo to BAY 3401016 |
|
| The Peggy and Harold Katz Family Drug Discovery Center - Nephrology |
| Not yet recruiting |
| Miami |
| Florida |
| 33136 |
| United States |
| Center for Advanced Pediatrics - Nephrology | Not yet recruiting | Atlanta | Georgia | 30329 | United States |
| Cardio Renal Institute | Recruiting | Chubbuck | Idaho | 83202 | United States |
| Tufts Medical Center | Nephrology Department | Recruiting | Boston | Massachusetts | 02111 | United States |
| Renal Disease Research Institute | Landry | Recruiting | Dallas | Texas | 75246 | United States |
| Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares S.A. | Recruiting | Santa Fe | Santa Fe Province | S3000EPV | Argentina |
| Hospital Británico | Recruiting | Buenos Aires | C1280AEB | Argentina |
| Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) | Recruiting | Buenos Aires | C1431FWO | Argentina |
| Centro de Rehabilitacion Cardiovascular | San Luis, Argentina | Recruiting | San Luis | D5700CGR | Argentina |
| St Joseph's Healthcare Hamilton | Cardiology | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
| University Hospital | Nephrology | Not yet recruiting | London | Ontario | N6A 5A5 | Canada |
| Lakeridge Health | Nephrology | Not yet recruiting | Whitby | Ontario | L1N 5T2 | Canada |
| Montreal General Hospital | Nephrology | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Centre hospitalier universitaire de Québec (CHUQ) | Nephrology | Recruiting | Québec | G1R 2J6 | Canada |
| Peking University First Hospital - Department of Pediatrics | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Children's Hospital of Chongqing Medical University - Department of Nephrology | Not yet recruiting | Chongqing | Chongqing Municipality | 401122 | China |
| The First Affiliated Hospital, Sun Yat-sen University - Department of Pediatrics | Recruiting | Guangzhou | Guangdong | 510080 | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology - Pediatric Nephrology and Immunology | Recruiting | Wuhan | Hubei | 430205 | China |
| Children's Hospital, Zhejiang University School of Medicine - Department of Nephrology | Recruiting | Hangzhou | Zhejiang | 310052 | China |
| Fakultní nemocnice Hradec Kralové - Nefrologická klinika | Recruiting | Hradec Králové | Hradec Králové Region | 500 05 | Czechia |
| Všeobecná fakultní nemocnice v Praze - Klinika nefrologie | Not yet recruiting | Prague | Prague | 128 08 | Czechia |
| CHU de Brest - Hopital La Cavale Blanche - Service de Nephorologie-Hémodialyse-Transplantation | Recruiting | Brest | Brittany Region | 29200 | France |
| CHU bordeaux - Hopital Pellegrin - Service de Nephrologie-Transplantation-Dialyse-Aphereses | Not yet recruiting | Bordeaux | New Aquitaine | 33076 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Nephrologie et transplantation d'organes | Recruiting | Toulouse | Occitanie | 31400 | France |
| Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades - Service d'Hopital De Jour Néphrologie adulte | Recruiting | Paris | Île-de-France Region | 75015 | France |
| Universitaetsklinikum Erlangen - Medizinische Klinik 4, Nephrologie, Hypertensiologie | Recruiting | Erlangen | Bavaria | 91054 | Germany |
| Universitaetsmedizin Goettingen (UMG) - Klinik fuer Nephrologie und Rheumatologie | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
| Universitaetsklinikum Koeln - Klinik II fuer Innere Medizin - Nephrologie, Rheumatologie, Diabetologie, Innere Medizin | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Charité Mitte - Nephrologie und Internistische Intensivmedizin | Not yet recruiting | Berlin | 10117 | Germany |
| Mavani Research Center | Not yet recruiting | Ahmedabad | Gujarat | 380052 | India |
| All India Institute of Medical Sciences (AIIMS) - New Delhi | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
| K.G. Hospital | Recruiting | Coimbatore | Tamil Nadu | 641018 | India |
| The Institute of Post Graduate Medical Education & Research (IPGMER) (SSKM Hospital) | Recruiting | Kolkata | West Bengal | 700020 | India |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Nefrologia, Dialisi e Trapianto | Recruiting | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Nefrologia | Recruiting | Brescia | 25123 | Italy |
| IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene | Recruiting | Genova | 16147 | Italy |
| Ospedale Pediatrico Bambino Gesù - Nefrologia | Recruiting | Roma | 00165 | Italy |
| Japanese RedCross Aichi Medical Center Nagoya Daini Hospital | Recruiting | Nagoya | Aichi-ken | 466-8650 | Japan |
| Kobe University Hospital | Not yet recruiting | Kobe | Hyōgo | 650-0017 | Japan |
| Saitama Prefectural Children's Medical Center | Recruiting | Chuo-Ku | Tokyo | 330-8777 | Japan |
| Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital | Recruiting | Osaka | 534-0021 | Japan |
| CSK U.M. Lodz - Klin. Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnetrznych Samodz. Publiczny Zaklad OZ | Withdrawn | Lodz | 92-213 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu - Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych | Recruiting | Poznan | 60-355 | Poland |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy - Centrum Wsparcia Badan Klinicznych | Recruiting | Warsaw | 04-141 | Poland |
| Hospital de Curry Cabral - Nephrology Department | Not yet recruiting | Lisbon | 1069-166 | Portugal |
| Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Nefrologia | Recruiting | Porto | 4200-319 | Portugal |
| Hospital de Torres Novas - Nephrology Department | Recruiting | Torres Novas | 2350-399 | Portugal |
| Unidade Local de Saude de Gaia/Espinho E.P.E Nephrology Department | Recruiting | Vila Nova de Gaia | 4434-502 | Portugal |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Hospital General La Mancha Centro | Nephrology | Not yet recruiting | Alcázar de San Juan | Ciudad Real | 13600 | Spain |
| Hospital Universitari Vall D Hebron | Nefrologia | Recruiting | Barcelona | 08035 | Spain |
| Fundacio Puigvert | Nefrologia | Not yet recruiting | Barcelona | 8025 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Del Rocio S.L. | Nefrologia | Recruiting | Seville | 41013 | Spain |
| Royal Devon University Healthcare NHS Foundation Trust | Royal Devon and Exeter Hospital - Renal Unit | Recruiting | Exeter | Devon | EX2 5DW | United Kingdom |
| Royal Free London NHS Foundation Trust | Royal Free Hospital - Centre for Nephrology | Recruiting | London | Greater London | NW3 2QG | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Northern General Hospital - Sheffield Kidney Institute | Not yet recruiting | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| South Tyneside and Sunderland NHS Foundation Trust | Sunderland Royal Hospital - Renal Unit | Recruiting | Sunderland | Tyne and Wear | SR4 7TP | United Kingdom |
| ID | Term |
|---|---|
| D009394 | Nephritis, Hereditary |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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