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Clinical Trial Details

Trial ID: L0051
Source ID: NCT04968184
Associated Drug: Placebo
Title: Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
Acronym: Clarion-CKD
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Placebo|DRUG: KBP-5074
Outcome Measures: Primary: Change in seated trough cuff SBP from baseline to Week 12, Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, will be evaluated., From baseline to Week 12|Change in seated trough cuff SBP from Week 48 to Week 52, Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, will be evaluated., Week 48 to Week 52 | Secondary: Change in seated trough cuff SBP from baseline to Week 24, Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, will be evaluated., From baseline to Week 24|Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24, Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated., From baseline to Week 12 and Week 24|Changes in seated trough cuff SBP and DBP from baseline to Week 48, Effect of KBP-5074 on SBP and DBP by assessing change in seated trough cuff SBP and DBP, will be evaluated., From baseline to Week 48|Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline, Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated., From baseline to Week 12 and Week 24|Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline, Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated., From baseline to Week 12 and Week 24|Changes in UACR from baseline to Week 12, Week 24, and Week 48, Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and \<300 mg/g) at baseline, will be evaluated., From baseline to Week 12, Week 24, and Week 48|Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48, Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and \<300 mg/g) at baseline, will be evaluated., From baseline to Week 12, Week 24, and Week 48|Change in seated trough cuff DBP from Week 48 to Week 52, Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated., Week 48 to Week 52|Change in UACR from Week 48 to Week 52, Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and \<300 mg/g) at baseline, will be evaluated., Week 48 to Week 52|Percentage change in UACR from Week 48 to Week 52, Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and \<300 mg/g) at baseline, will be evaluated., Week 48 to Week 52|Number of participants with adverse events (AEs) and serious adverse events (SAEs), The safety and tolerability of KBP-5074,will be evaluated., Screening (Week -6 to -2) until EOS (Week 56) or Unscheduled visit or end of treatment or early termination
Sponsor/Collaborators: Sponsor: KBP Biosciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 652
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-11-05
Completion Date: 2024-07-10
Results First Posted:
Last Update Posted: 2024-08-13
Locations: G & L Research, LLC, Foley, Alabama, 36535, United States|Apogee Clinical Research, LLC, Huntsville, Alabama, 35805, United States|Aventiv Research, Inc, Mesa, Arizona, 85210, United States|National Heart Institute, Beverly Hills, California, 90211-2285, United States|Amicis Research Center (Valencia), Granada Hills, California, 91324, United States|Amicis Research Center, Granada Hills, California, 91344, United States|Amicis Research Center, Lancaster, California, 93534, United States|Renal Consultants Medical Group - Granada Hills, Northridge, California, 91325, United States|United Clinical Research and Innovations, S. Gate, California, 90280, United States|Solano Kidney Care, Vacaville, California, 95687-3557, United States|Desert Cities Dialysis - Amethyst, Victorville, California, 92392, United States|Kidney and Hypertension Center, Victorville, California, 92395, United States|Davita Clinical Research-Hartford, Bloomfield, Connecticut, 06002, United States|Synergy Healthcare, Bradenton, Florida, 34208, United States|San Marcus Research Clinic, Inc., Miami Lakes, Florida, 33014-5602, United States|Inpatient Research Clinic, LLC, Miami Lakes, Florida, 33014, United States|Homestead Associates in Research, Inc, Miami, Florida, 33032-8225, United States|Total Research Group, Miami, Florida, 33126-3422, United States|LCC Medical Research, Miami, Florida, 33126, United States|Oceane 7 Medical&Research Center, Inc., Miami, Florida, 33144, United States|Allied Biomedical Research Institute, Miami, Florida, 33155, United States|South Florida Research Phase I-Iv, Inc., Miami, Florida, 33166, United States|New Generation Of Medical Research, Naples, Florida, 34104, United States|Sarkis Clinical, Ocala, Florida, 34471, United States|Omega Research Orlando, LLC, Orlando, Florida, 32808, United States|Genesis Clinical Research, Tampa, Florida, 33603, United States|Santos Research Center CORP, Tampa, Florida, 33604, United States|Fides Clinical Research, Atlanta, Georgia, 30342, United States|Southeastern Clinical Research Institute, LLC, Augusta, Georgia, 30904, United States|Columbus Associates LLC, Columbus, Georgia, 31904-3650, United States|Central Georgia Kidney Specialists, Macon, Georgia, 31201-6863, United States|Clinical Investigation Specialists, Inc., Gurney, Illinois, 60031, United States|Massachusetts General Hospital (MGH) - Renal Associates Clinic, Boston, Massachusetts, 02114, United States|InterMed Consultants, Edina, Minnesota, 55435-2129, United States|Healthcare Research Network, Hazelwood, Missouri, 63042, United States|Clinical Research Consultants, Kansas City, Missouri, 64111-5964, United States|St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office, Saint Louis, Missouri, 63136-6111, United States|Healor Primary Care /CCT Research, Las Vegas, Nevada, 89102-1682, United States|DaVita Clinical Research (Nevada), Las Vegas, Nevada, 89128, United States|Albert Einstein's College of Medicine, Bronx, New York, 10461-1900, United States|Kidney Medical Associates, PLLC, Bronx, New York, 10461-2710, United States|NYC Health + Hospitals / Queens - Diabetes Center of Excellence, Jamaica, New York, 11432, United States|Mattoo & Bhat Medical Associates, PC, Ridgewood, New York, 11385, United States|Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville, Asheville, North Carolina, 28801-4104, United States|Physicians East, PA, Greenville, North Carolina, 27834, United States|Eastern Nephrology Associates - Jacksonville, Jacksonville, North Carolina, 28546, United States|Eastern Nephrology Associates - New Bern, New Bern, North Carolina, 28562-5200, United States|North Carolina Nephrology P.A., Raleigh, North Carolina, 27609-7511, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103-7108, United States|Providence Health Partners-Center for Clinical Research, Dayton, Ohio, 45439, United States|Columbia Nephrology Associates, PA, Columbia, South Carolina, 29203-6476, United States|Knoxville Kidney Center, PLLC, Knoxville, Tennessee, 37923-3624, United States|Gamma Clinical Research Institute, Austin, Texas, 78503, United States|Davita Clinical Research El Paso, El Paso, Texas, 79925, United States|Kidney Consultants of El Paso, P.A., El Paso, Texas, 79935, United States|DaVita Clinical Research Houston, Houston, Texas, 77004, United States|Pioneer Research Solutions, Inc., Houston, Texas, 77099, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212-4738, United States|Urology San Antonio - North Central, San Antonio, Texas, 78229-3342, United States|DaVita Clinical Research, San Antonio, Texas, 78251, United States|Kidney Specialists of North Houston, PLLC, The Woodlands, Texas, 77384, United States|Davita Norfolk Square, Norfolk, Virginia, 23502, United States|Dominion Medical Associates, Inc., Richmond, Virginia, 23219, United States|Clinical Investigation Specialists, Kenosha, Wisconsin, 53142, United States|Milwaukee Nephrologists, SC (Rich), Wauwatosa, Wisconsin, 53226, United States|Renal Research, Gosford, New South Wales, 2250, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|Austin Hospital, Heidelberg, Victoria, 3084, Australia|Clinical Center University of Sarajevo, Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina|Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology, Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina|The University Hospital Foca, Foca, Republika Srpska, 73300, Bosnia and Herzegovina|General Hospital Gradiska, Gradiska, Republika Srpska, 78400, Bosnia and Herzegovina|General hospital Trebinje - Gastroenterology, Trebinje, Republika Srpska, 89101, Bosnia and Herzegovina|General Hospital Tesanj, Tešanj, Zeničko-dobojski Kanton, 72460, Bosnia and Herzegovina|5 th MHAT, Sofia, Sofia-Grad, 1233, Bulgaria|Medical Center Excelsior, Sofia, Sofia-Grad, 1407, Bulgaria|UMHAT St. Ekaterina, Sofia, Sofia-Grad, 1431, Bulgaria|Comac Medical Ltd, Sofia, Sofia-Grad, 1612, Bulgaria|Mhat Dr.Tota Venkova, Gabrovo, 5300, Bulgaria|Medical Center Hera EOOD, Montana, 3400, Bulgaria|UMHAT Kaspela, Plovdiv, 4002, Bulgaria|Medical Center "Teodora", Ruse, 7012, Bulgaria|DCC 22 - Sofia, Sofia, 1113, Bulgaria|Medical Center Hera EOOD, Sofia, 1510, Bulgaria|Medical Center ''Synexus Sofia'' EOOD, Sofia, 1784, Bulgaria|University Hospital of Active Treatment Prof. Stoyan Kirkovich, Stara Zagora, 6000, Bulgaria|MHAT"Sv.Anna-Varna"AD, Varna, 9002, Bulgaria|Dr. Stephen S. Chow Medicine Professional Corporation, Toronto, Ontario, M4C 5T2, Canada|Clinical Research Solutions Incorporated, Waterloo, Ontario, N2T 0C1, Canada|Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing, 100020, China|Beijing An Zhen Hospital, Capital Medical University, Beijing, Beijing, 100029, China|China-Japan Friendship Hospital, Beijing, Beijing, 100029, China|Peking University First Hospital, Beijing, Beijing, 100034, China|Beijing Hospital, Beijing, Beijing, 100730, China|The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China|The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China|Zhongshan Hospital Xiamen University, Xiamen, Fujian, 361004, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China|Guangzhou First People's Hospital - Nephrology, Guangzhou, Guangdong, 510180, China|The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510655, China|The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology, Nanning, Guangxi, 530021, China|The Affliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550004, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 50004, China|The First Affiliated Hospital of Zhengzhou University (East Compus), Zhengzhou, Henan, China|The Central Hospital of Wuhan, Wuhan, Hubei, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China|Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210029, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Nei Mongol (mn), 014010, China|General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China|Shandong Provincial Hospital, Jinan, Shandong, China|Yantai Yuhuangding Hospital(Base Cpmpus), Yantai, Shandong, 264000, China|Shanghai General Hospital, Shanghai, Shanghai, 200000, China|Sichuan Academy of Medical Sciences, Chengdu, Sichuan, 610072, China|The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China|Zhejiang Hospital, Hangzhou, Zhejiang, China|Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China|Jinhua Central Hospital, Jinhua, Zhejiang, 321000, China|The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China|The Southwest Hospital of AMU, Chongqing, 400038, China|Shanghai Sixth People's Hospital, Shanghai, 200233, China|Tianjin Medical University General Hospital, Tianjin, 300052, China|University Hospital Centre Zagreb, Zagreb, Grad Zagreb, 10000, Croatia|Opca bolnica Vinkovci, Vinkovci, Osjecko-baranjska Županija, 32100, Croatia|University Hospital Center Split, Split, 21000, Croatia|Nefrologie s.r.o., Praha, Praha 4, 149 00, Czechia|Nemocnice Trebic, p.o., Trebic, Třebíč, 674 01, Czechia|IKEM, Praha 4, 140 21, Czechia|Alaron s.r.o., Praha 6, 160 00, Czechia|LTD "High technology hospital MEDCENTER", Batumi, Ajaria, 6000, Georgia|Ltd Marnecor, Marneuli, Kvemo Kartli, 3000, Georgia|Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital, Gori, Shida Kartli, 1400, Georgia|JSC "Evex Hospitals', Batumi, 6010, Georgia|Aleksandre Aladashvili Clinic LLC, Tbilisi, 0102, Georgia|LTD Israel-Georgian Medical Research Clinic Helsicore, Tbilisi, 0112, Georgia|"Pineo Medical Ecosystem"LTD, Tbilisi, 0114, Georgia|JSC German Clinic, Tbilisi, 0119, Georgia|National Center of Urology Named after Laur Managadze, Tbilisi, 0144, Georgia|Bokhua Memorial Cardiovascular Centre, Tbilisi, 0159, Georgia|Emergency Cardiology Center named by acad. G. Chapidze, Tbilisi, 0159, Georgia|J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery", Tbilisi, 0159, Georgia|Nephrologisches Zentrum Villingen-Schwenningen, Villingen-Schwenningen, Baden-Württemberg, 78052, Germany|Diabeteszentrum DO, Dortmund, Nordrhein-Westfalen, 44137, Germany|DaVita Clinical Research Germany GmbH, Düsseldorf, Nordrhein-Westfalen, 23538, Germany|Universitätsklinikum Mainz, Mainz, Rheinland-Pfalz, 55131, Germany|Charité- Universitätsmedizin Berlin, Berlin, 10117, Germany|Charité - Universitätsmedizin Berlin, Berlin, 12203, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Universitätsklinikum Jena, Jena, 07747, Germany|Queen Mary Hospital - Medicine, Hong Kong, Hong Kong|Tung Wah Hospital, Hong Kong, Hong Kong|Coromed-Smo Kft., Pécs, Baranya, 7624, Hungary|IPR Hungary Kft., Miskolc, Borsod-Abaúj-Zemplén, 3530, Hungary|Sonocor Egészségügyi Szolgáltató Kft., Szeged, Csongrád, 6725, Hungary|TaNa Med Kft, Mosonmagyaróvár, Gyor-Moson-Sopron, 7624, Hungary|BKS Research, Hatvan, Heves, H-3000, Hungary|Kistarcsai Flor Ferenc Korhaz, Kistarcsa Hungary, Pest, 2143, Hungary|DRC Gyógyszervizsgáló Központ Kft., Balatonfüred, Veszprém City, 8230, Hungary|Semmelweis Egyetem, Budapest, 1083, Hungary|Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet, Budapest, 1204, Hungary|Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, H-7400, Hungary|Rabin Medical Center, Petah Tikwa, HaMerkaz, 49100, Israel|Nazareth Hospital EMMS, Nazareth, HaZafon, 16100, Israel|Chungnam National University Hospital - Nephrology, Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], 35015, Korea, Republic of|National Health Insurance Service Ilsan Hospital - Nephrology, Goyang-si, Gyeonggido [Kyonggi-do], 10444, Korea, Republic of|Seoul National University Hospital - Nephrology, Jongno-gu, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080, Korea, Republic of|Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6273, Korea, Republic of|Samsung Medical Center - Nephrology, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351, Korea, Republic of|The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591, Korea, Republic of|Dace Teterovska - Doctor's Practice, Ogre, Ogres Novads, Latvia|P.Stradina Clinical University Hospital, Riga, Latvia|Saules seimos medicinos centras, Kaunas, Kauno Apskritis, LT-49449, Lithuania|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, 15586, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, Perak, 30450, Malaysia|Hospital Seri Manjung, Seri Manjung, Perak, 32400, Malaysia|Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 50586, Malaysia|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|NZOZ Euromedica Sp. z o.o., Grudziądz, Kujawsko-pomorskie, 86-300, Poland|Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer, Lodz, Lódzkie, 94-074, Poland|Synexus Polska Sp. z o.o., Katowice, 40-040, Poland|Synexus Polska Sp. z. o.o., Lodz, 90127, Poland|SP ZOZ Centralny Szpital Kliniczny UM w Lodzi, Lodz, 92-213, Poland|Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin, 20954, Poland|Synexus Polska Sp. z o.o., Poznan, 60-702, Poland|Synexus Polska Sp. z o.o., Warszawa, 02-672, Poland|WroMedica I. Bielicka, A. Strzalkowska s.c., Wrocław, 51-685, Poland|Clinical Hospital Centre Zemun, Zemun, Belgrade, 11080, Serbia|Clinical Centre Nis, Niš, Nišavski Okrug, 18000, Serbia|Clinical Center Vojvodina, Novi Sad, Vojvodina, 21000, Serbia|Military Medical Academy, Belgrade, 11000, Serbia|Zvezdara University Medical Center, Belgrade, 11000, Serbia|MSB General hospital - Clinical Research Center, Belgrade, Serbia|Clinical Center Kragujevac, Kragujevac, 33126-3422, Serbia|Iatros International, Bloemfontein, Free State, 9301, South Africa|Charlotte Maxeke Johannesburg Hospital, Soweto, Gauteng, 2193, South Africa|Office of Gulam Hoosain Vally, Durban, Kwazulu-Natal, 4001, South Africa|Tiervlei Trial Centre, Bellville, Cape Town, Western Cape, 7530, South Africa|Dr J.M. Engelbrecht Trial Site, Somerset West, Western Cape, 7130, South Africa|Hospital público da Mariña, Burela, Lugo, 27880, Spain|Hospital Ribera Polusa, Burela, Lugo, 27880, Spain|Consorcio Hospital General Universitario de Valencia, Valencia, Valenciana, Comunidad, 46014, Spain|FUNDACION PUIGVERT - Nephrology Department, Barcelona, 08025, Spain|Hospital del Mar, Barcelona, 8003, Spain|Hospital Quironsalud Barcelona, Barcelona, 8023, Spain|Hospital de La Santa Creu i Sant Pau, Barcelona, 8035, Spain|Hospital Universitario Virgen de las Nieves, Granada, 18014, Spain|Hospital Universitario Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital Universitario Y Politécnico La Fe, Valencia, 46026, Spain|Taichung Veterans General Hospital - Nephrology, Taichung, Taichung Municipality, 40705, Taiwan|National Taiwan University Hospital - Nephrology, Taipei, Taipei Special Muncipality, 10002, Taiwan|China Medical University Hospital - Nephrology - Taichung, Taichung, 406, Taiwan|Taipei Medical University - Shuang Ho Hospital - Nephrology, Taipei, 110, Taiwan|Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology, Taoyuan, 33305, Taiwan
URL: https://clinicaltrials.gov/show/NCT04968184

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress