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Clinical Trial Details

Trial ID: L0215
Source ID: NCT04507061
Associated Drug: Runcaciguat
Title: Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.
Acronym: CONCORD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: runcaciguat|OTHER: Placebo
Outcome Measures: Primary: Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment, From baseline up to day 57 (± 3) | Secondary: Number of subjects with treatment emergent adverse event (TEAE), From first treatment administration up to end of follow up (Day 87±7)|Number of subjects with early discontinuations, From first treatment administration up to end of treatment (Day 57±3)
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 243
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-09-01
Completion Date: 2022-04-05
Results First Posted:
Last Update Posted: 2023-04-04
Locations: Medizinische Universität Innsbruck, Innsbruck, 6020, Austria|Klinik Landstraße - Krankenhaus Rudolfstiftung, Wien, 1030, Austria|Zentrum f. klinische Studien Dr. Hanusch GmbH, Wien, 1060, Austria|Universitätsklinikum AKH Wien, Wien, 1090, Austria|Klinik Hietzing, Wien, 1130, Austria|OL Vrouwziekenhuis - Campus Aalst, Aalst, 9300, Belgium|Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles - Brussel, 1070, Belgium|UZ Gent, Gent, 9000, Belgium|UZ Leuven Gasthuisberg, Leuven, 3000, Belgium|Med Centre Diamedical 2013, Dimitrovgrad, 6400, Bulgaria|Multiprofile Hospital for Active Treatment Medline Clinic, Plovdiv, 4000, Bulgaria|MHAT Sveta Karidad, Plovdiv, 4004, Bulgaria|MHAT Dr. Bratan Shukerov AD, Smolyan, 4700, Bulgaria|MHAT "Knyaginya Klementina - Sofia"EAD, Sofia, 1233, Bulgaria|MC Kalimat, Sofia, 1680, Bulgaria|MCOMH Preventsia-2000, Stara Zagora, 6000, Bulgaria|Region Nordjylland | Aalborg University Hospital - Cardiology Department, Aalborg, 9000, Denmark|Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark|Regionshospitalet Gødstrup, Herning, 7400, Denmark|Holbæk Sygehus, Holbæk, 4300, Denmark|Sygehus Lillebaelt | Kolding Sygehus - Medicinske Sygdomme, Kolding, 6000, Denmark|Odense Universitetshospital, Endokrinologisk Afd. M, Odense C, 5000, Denmark|StudyCor Oy, Jyväskylä, 40620, Finland|Diagnos Klaukkalan Lääkäriasema, Klaukkala, 01800, Finland|Satucon / Kuopion Työterveys, Kuopio, 70100, Finland|Omena Terveys Oy, Seinäjoki, 60320, Finland|Turun yliopistollinen keskussairaala, Turku, 20521, Finland|Klinikum der Universität Würzburg, Wuerzburg, Bayern, 97080, Germany|Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW), Bad Oeynhausen, Nordrhein-Westfalen, 32545, Germany|DaVita Clinical Research Deutschland GmbH, Duesseldorf, Nordrhein-Westfalen, 40210, Germany|InnoDiab Forschung GmbH, Essen, Nordrhein-Westfalen, 45136, Germany|Medamed Studienambulanz GmbH, Leipzig, Sachsen, 04315, Germany|Barzilai Medical Center | Nephrology & Hypertension Dept., Ashkelon, 7830604, Israel|Lady Davis Carmel Medical Center, Haifa, 3436212, Israel|Edith Wolfson Medical Center, Holon, 5822012, Israel|Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, 9112001, Israel|Health Corporation of Galilee Medical Center, Nahariya, 2210001, Israel|Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva, 4941492, Israel|Chaim Sheba Medical Center, Ramat Gan, 5262000, Israel|Poriya Medical Center | Nephrology and Hypertension Dept., Tiberius, 1528001, Israel|A.O.U. Luigi Vanvitelli, Napoli, Campania, 80131, Italy|A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna, Emilia-Romagna, 40138, Italy|IRCCS Ospedale Policlinico San Martino, Genova, Liguria, 16132, Italy|Istituto Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Lombardia, 24020, Italy|Ospedale San Raffaele s.r.l., Milano, Lombardia, 20132, Italy|IRCCS Centro Cardiologico Monzino S.p.A, Milano, Lombardia, 20138, Italy|Centralny Szpital Kliniczny MSWiA w Warszawie, Warszawa, 02-507, Poland|FMC-dialyzacne sluzby, s.r.o. - Kosice, Kosice, 040 11, Slovakia|BIODIAL, spol. s r.o., Puchov, 020 01, Slovakia|Medivasa s.r.o., Zilina, 01001, Slovakia|Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial, Ferrol, A Coruña, 15405, Spain|Complejo Hosp. Univ. A Coruña | Endocrinologia y Nutricion, A Coruña, 150006, Spain|Hospital del Mar, Barcelona, 08003, Spain|Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, 08023, Spain|Hospital Quirón, Barcelona, 08023, Spain|Hospital Universitario Virgen de las Nieves|Medicina Interna, Granada, 18014, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Dr. Peset, Valencia, 46017, Spain|PTC-Primary care Trial Center, Göteborg, 413 46, Sweden|Clemenstorget Hjärtmottagning, Lund, 222 21, Sweden|Akademiska Sjukhuset Njurmottagningen, Uppsala, 751 85, Sweden|ClinSmart, Uppsala, 752 37, Sweden|Medical center LLC " Fresenius medical care Ukraine", Cherkasy, 18009, Ukraine|Dnepropetrovsk regional hospital n.a. I. I. Mechnikov, Dnipro, 49005, Ukraine|Private enterprise private production company " Acinus", Kropyvnytskyi, 25006, Ukraine|Kyiv City Center of Nephrology and Dialysis, Kyiv, 01023, Ukraine|Medical Center of Edelweiss Medics LLC, Kyiv, 02002, Ukraine|Kyiv City Center of Nephrology and Dialysis, Kyiv, 02660, Ukraine|Volyn Regional Clinical Hospital, Lutsk, 43005, Ukraine|Ternopil Regional Clinical Hospital, Ternopil, 46002, Ukraine|Zaporizhzhia Regional Clinical Hospital, Zaporizhzhya, 69600, Ukraine
URL: https://clinicaltrials.gov/show/NCT04507061

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress