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Clinical Trial Details

Trial ID: L0191
Source ID: NCT04736628
Associated Drug: Avenciguat
Title: A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04736628/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Avenciguat|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment, Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. | Secondary: Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment, Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20., The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.|Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment, Number of patients achieving urine albumin creatinine ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment. During the 10-hour period every time the patient urinates, and the patient collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample., At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.|Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment, Number of patients achieving urine albumin creatinine ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day., At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 261
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04-27
Completion Date: 2023-09-21
Results First Posted: 2024-09-04
Last Update Posted: 2024-09-04
Locations: Clearview Medical Research, LLC, Canyon Country, California, 91351, United States|Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California, 91730, United States|Kidney & Hypertension Center, Victorville, California, 92395, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Nephrology Associates, P.A., Newark, Delaware, 19713, United States|Indago Research and Health Center, Hialeah, Florida, 33012, United States|Panax Clinical Research, Miami Lakes, Florida, 33014, United States|Homestead Associates in Research, Miami, Florida, 33032, United States|Bioclinical Research Alliance, Inc., Miami, Florida, 33155, United States|Alma Clinical Research, Inc., Miami, Florida, 33165, United States|Davita Clinical Research, Columbus, Georgia, 31904, United States|Meridian Clinical Research, LLC, Savannah, Georgia, 31406, United States|Boise Kidney and Hypertension, PLLC, Boise, Idaho, 83706, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|Renal Associates of Baton Rouge, Baton Rouge, Louisiana, 70808, United States|DaVita Clinical Research, Las Vegas, Nevada, 89128, United States|Nevada Kidney Disease and Hypertension Centers, PLLC, Las Vegas, Nevada, 89128, United States|New Jersey Kidney Care, LLC, Jersey City, New Jersey, 07305, United States|Brookview Hills Research Associates LLC, Winston-Salem, North Carolina, 27103, United States|Knoxville Kidney Center PLLC, Knoxville, Tennessee, 37923, United States|Davita Clinical Research, El Paso, Texas, 79925, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212, United States|Kidney Specialists of North Houston, PLLC, Shenandoah, Texas, 77384, United States|STAT Research, Caba, C1023AAB, Argentina|CEDIC - Centro de Investigacion Clinica, Caba, C1060ABN, Argentina|CEMIC, Caba, C1431FWO, Argentina|Instituto Privado de Investigaciones Clínica Córdoba S.A., Cordoba, X5000AAW, Argentina|Centro de Investigaciones Médicas Mar del Plata, Mar del Plata, B7600FYK, Argentina|Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata, B7600FZN, Argentina|Instituto Médico Catamarca - IMEC, Rosario, S2000AJU, Argentina|CEDIR Santa Fe, Santa Fe, S3000FSP, Argentina|CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial, Sarandi, B1872EEB, Argentina|Renal Research, Gosford, Gosford, New South Wales, 2250, Australia|Nepean Hospital, Kingswood, New South Wales, 2747, Australia|Macquarie University, Macquarie Park, New South Wales, 2109, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Westmead Hospital, Westmead, New South Wales, 2145, Australia|Austin Health, Heidelberg, Victoria, 3084, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|CARe Clinic, Red Deer, Alberta, T4P 1K4, Canada|Stouffville Medical Centre, Stouffville, Ontario, L4A 1H2, Canada|Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada|Albion Finch Medical Centre, Toronto, Ontario, M9V 4B4, Canada|Fadia El Boreky Medicine Professional, Waterloo, Ontario, N2J 1C4, Canada|Peking University First Hospital, Beijing, 100034, China|Peking University People's Hospital, Beijing, 100044, China|Peking University Third Hospital, Beijing, 100191, China|People's Hospital of Sichuan Province, Chengdu, 610072, China|Second Affiliated Hospital Chongqing Medical University, Chongqing, 400016, China|The People's Hospital Of Xuancheng City, Xuancheng, 242000, China|Aarhus University Hospital, Aarhus N, 8200, Denmark|Herlev and Gentofte Hospital, Herlev, 2730, Denmark|Holbæk Sygehus, Holbæk, 4300, Denmark|Sjællands Universitetshospital, Roskilde, 4000, Denmark|Klinikum Region Hannover GmbH, Hannover, 30459, Germany|Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, 23538, Germany|Prince of Wales Hospital, Hong Kong, 999077, Hong Kong|Princess Margaret Hospital, Hong Kong, 999077, Hong Kong|Queen Mary Hospital, Hong Kong, 999077, Hong Kong|Tung Wah Hospital, Hong Kong, Hong Kong|Chubu Rosai Hospital, Aichi, Nagoya, 455-8530, Japan|Daido Hospital, Aichi, Nagoya, 457-8511, Japan|Juntendo University Urayasu Hospital, Chiba, Urayasu, 279-0021, Japan|Kurume University Hospital, Fukuoka, Kurume, 830-0011, Japan|Nakayamadera Imai Clinic, Hyogo, Takarazuka, 665-0861, Japan|Takai Naika Clinic, Kanagawa, Kamakura, 247-0056, Japan|Kyoto University Hospital, Kyoto, Kyoto, 606-8507, Japan|Kuana City Medical Center, Mie, Kuwana, 511-0061, Japan|Shinshu University Hospital, Nagano, Matsumoto, 390-8621, Japan|Kawasaki Medical School Hospital, Okayama, Kurashiki, 701-0192, Japan|Saitama Medical University Hospital, Saitama, Iruma-gun, 350-0495, Japan|Yaizu City Hospital, Shizuoka, Yaizu, 425-8505, Japan|The University of Tokyo Hospital, Tokyo, Bunkyo-ku, 113-8655, Japan|Tokyo-Eki Center-building Clinic, Tokyo, Chuo-ku, 103-0027, Japan|Nihon University Itabashi Hospital, Tokyo, Itabashi-ku, 173-8610, Japan|University Kebangsaan Malaysia, Cheras, Kuala Lumpur, 56000, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, Perak, 30450, Malaysia|Universiti Sains Malaysia Hospital, Kelantan, 16150, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia|Hospital Selayang, Selangor, 68100, Malaysia|Centro de Investigacion Cardiometabolica de Aguascalientes, Aguascalientes, 20230, Mexico|Centenario Hospital Miguel Hidalgo, Aguascalientes, 20259, Mexico|Instituto Nacional de Cardiologia Ignacio Chavez, Ciudad de Mexico, 14080, Mexico|Instituto Nacional de Cs Médicas y Nutrición S Zubiran, Ciudad de México, 14000, Mexico|Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, 64460, Mexico|Clinstile S.A. de C.V., México, 06700, Mexico|Dunedin Hospital, Dunedin, 9054, New Zealand|P3 Research Kapiti, Paraparaumu, 5032, New Zealand|P3 Research, Tauranga, 3110, New Zealand|Cardiovascular Centre of Malopolska, Chrzanow, 32-500, Poland|Pratia MCM Krakow, Krakow, 30-510, Poland|Cent.Clin.Hosp.Med.Univ.Lodz, Lodz, 92-213, Poland|Medicome Limited Liability Company, Oswiecim, 32600, Poland|ULS da Região de Aveiro, Aveiro, 3810-164, Portugal|CHLO, EPE - Hospital de Santa Cruz, Carnaxide, 2790-134, Portugal|ULS de Santa Maria, E.P.E, Lisboa, 1649-035, Portugal|Centro Hospitalar Universitário São João,EPE, Porto, 4200-319, Portugal|Moscow 1st State Med.Univ.n.a.I.M.Sechenov, Moscow, 119992, Russian Federation|St. Petersburg GUZ City Hospital no. 31, St. Petersburg, St. Petersburg, 197110, Russian Federation|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital de Bellvitge, L'Hospitalet de Llobregat, 08907, Spain|Fundación Jiménez Díaz, Madrid, 28040, Spain|Clínica Universidad de Navarra, Pamplona, 31008, Spain|Hospital Virgen Macarena, Sevilla, 41009, Spain|Hospital Clínico de Valencia, Valencia, 46010, Spain|Hospital Dr. Peset, Valencia, 46017, Spain|ProbarE i Stockholm, Stockholm, 11329, Sweden|Lakeside Surgery, Corby, NN17 2UR, United Kingdom|University Hospital Coventry, Coventry, CV2 2DX, United Kingdom|Barts and The London School of Medicine and Dentistry, London, EC1M 6BQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04736628

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress