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Účinnost a bezpečnost KBP-5074 u nekontrolované hypertenze a středně těžkého nebo těžkého CKD (Clarion-CKD)

12. října 2026 aktualizováno: Novo Nordisk A/S

Randomizovaná dvojitě zaslepená placebem kontrolovaná multicentrická studie fáze 3 k posouzení účinnosti a bezpečnosti antagonisty receptoru mineralokortikoidů KBP-5074 u pacientů s nekontrolovanou hypertenzí a středně těžkou nebo těžkou (fáze 3b/4) CKD

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Detailní popis

Participants in this study will be recruited, screened, and enrolled at approximately 140 study sites globally.

The study will consist of the following periods:

  1. Pretreatment Phase: This will include prescreening assessment and screening period of up to 4 weeks and 2-week Open-label placebo Run-In period.
  2. A 24-week Double-blind Treatment Period (Randomization to Week 24) will include: An initial 12-week (Randomization to Week 12) and second 12-week (Week 12 to Week 24) treatment period and a second 12-week treatment period (Week 12 to Week 24), during both the periods study drug will be titrated.
  3. A 24-week Open-label Treatment Period (Week 24 to Week 48) during which eligible participants will receive Open-label KBP-5074.
  4. A 4-week Randomized Double-blind Withdrawal Period (Week 48 to Week 52) during which eligible participants will be randomized to continue their current KBP-5074 dose at the end of Open-label treatment or receive matching placebo for 4 weeks.
  5. A 4-week post-treatment Follow-Up Period (Week 52 to Week 56).

During, 24-week Double-blind Treatment Period, 24-week Open-label Treatment Period, and at 4-week Randomized Double-blind Withdrawal Period, the background antihypertensive medications change may or may not be allowed.

At Double-blind Treatment Period, eligible participants will be randomly assigned in a 1:1 ratio to KBP-5074 0.25 mg or matching placebo once daily (QD).

At the Randomized Double-blind Withdrawal Period, participants who meet the randomized withdrawal criteria will be randomly assigned in a 1:1 ratio to continue their current KBP-5074 dose at the end of the Open-label Treatment Period or matching placebo QD.

The study design included a pre-planned futility determination by an Independent Data Monitoring Committee (IDMC).

The trial was originally sponsored by KBP Biosciences PTE Ltd, but sponsorship was transferred to Novo Nordisk after the trial was terminated following the futility determination by IDMC.

Typ studie

Intervenční

Zápis (Aktuální)

666

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • New South Wales
      • Gosford, New South Wales, Austrálie, 2250
        • Renal Research
    • South Australia
      • Adelaide, South Australia, Austrálie, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Heidelberg, Victoria, Austrálie, 3084
        • Austin Hospital
  • Bosna a Hercegovina
    • Kanton Sarajevo
      • Sarajevo, Kanton Sarajevo, Bosna a Hercegovina, 71000
        • Clinical Center University of Sarajevo
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosna a Hercegovina, 78000
        • Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology
      • Foca, Republika Srpska, Bosna a Hercegovina, 73300
        • The University Hospital Foca
      • Gradiska, Republika Srpska, Bosna a Hercegovina, 78400
        • General Hospital Gradiska
      • Trebinje, Republika Srpska, Bosna a Hercegovina, 89101
        • General hospital Trebinje - Gastroenterology
    • Zeničko-dobojski Kanton
      • Tešanj, Zeničko-dobojski Kanton, Bosna a Hercegovina, 72460
        • General Hospital Tesanj
  • Bulharsko
      • Gabrovo, Bulharsko, 5300
        • Mhat Dr.Tota Venkova
      • Montana, Bulharsko, 3400
        • Medical Center Hera EOOD
      • Plovdiv, Bulharsko, 4002
        • UMHAT Kaspela
      • Rousse, Bulharsko, 7012
        • Medical Center "Teodora"
      • Sofia, Bulharsko, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulharsko, 1113
        • DCC 22 - Sofia
      • Sofia, Bulharsko, 1784
        • Medical Center ''Synexus Sofia'' EOOD
      • Stara Zagora, Bulharsko, 6000
        • University Hospital of Active Treatment Prof. Stoyan Kirkovich
      • Varna, Bulharsko, 9002
        • MHAT"Sv.Anna-Varna"AD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulharsko, 1233
        • 5 th MHAT
      • Sofia, Sofia-Grad, Bulharsko, 1407
        • Medical Center Excelsior
      • Sofia, Sofia-Grad, Bulharsko, 1431
        • UMHAT St. Ekaterina
      • Sofia, Sofia-Grad, Bulharsko, 1612
        • Comac Medical Ltd
  • Chorvatsko
      • Split, Chorvatsko, 21000
        • University Hospital Center Split
    • City of Zagreb
      • Zagreb, City of Zagreb, Chorvatsko, 10000
        • University Hospital Centre Zagreb
    • Osjecko-baranjska Županija
      • Vinkovci, Osjecko-baranjska Županija, Chorvatsko, 32100
        • Opca bolnica Vinkovci
  • Gruzie
      • Batumi, Gruzie, 6010
        • JSC "Evex Hospitals'
      • Tbilisi, Gruzie, 0102
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Gruzie, 0144
        • National Center of Urology Named after Laur Managadze
      • Tbilisi, Gruzie, 0112
        • LTD Israel-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Gruzie, 0114
        • "Pineo Medical Ecosystem"LTD
      • Tbilisi, Gruzie, 0119
        • JSC German Clinic
      • Tbilisi, Gruzie, 0159
        • Bokhua Memorial Cardiovascular Centre
      • Tbilisi, Gruzie, 0159
        • Emergency Cardiology Center named by acad. G. Chapidze
      • Tbilisi, Gruzie, 0159
        • J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
    • Adjara
      • Batumi, Adjara, Gruzie, 6000
        • LTD "High technology hospital MEDCENTER"
    • Kvemo Kartli
      • Marneuli, Kvemo Kartli, Gruzie, 3000
        • Ltd Marnecor
    • Shida Kartli
      • Gori, Shida Kartli, Gruzie, 1400
        • Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital
  • Hongkong
      • Hong Kong, Hongkong
        • Tung Wah Hospital
      • Hong Kong, Hongkong
        • Queen Mary Hospital - Medicine
  • Izrael
    • Central District
      • Petah Tikwa, Central District, Izrael, 49100
        • Rabin Medical Center
    • Northern District
      • Nazareth, Northern District, Izrael, 16100
        • Nazareth Hospital EMMS
  • Jižní Afrika
    • Free State
      • Bloemfontein, Free State, Jižní Afrika, 9301
        • Iatros International
    • Gauteng
      • Soweto, Gauteng, Jižní Afrika, 2193
        • Charlotte Maxeke Johannesburg Hospital
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Jižní Afrika, 4001
        • Office of Gulam Hoosain Vally
    • Western Cape
      • Cape Town, Western Cape, Jižní Afrika, 7530
        • Tiervlei Trial Centre
      • Somerset West, Western Cape, Jižní Afrika, 7130
        • Dr J.M. Engelbrecht Trial Site
  • Jižní Korea
      • Seoul, Jižní Korea, 03080
        • Seoul National University Hospital - Nephrology
    • Daejeon Gwang'yeogsi [Taejon-Kwangyokshi]
      • Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], Jižní Korea, 35015
        • Chungnam National University Hospital - Nephrology
    • Gyeonggido [Kyonggi-do]
      • Goyang-si, Gyeonggido [Kyonggi-do], Jižní Korea, 10444
        • National Health Insurance Service Ilsan Hospital - Nephrology
    • Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Jižní Korea, 6273
        • Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Jižní Korea, 6351
        • Samsung Medical Center - Nephrology
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Jižní Korea, 6591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M4C 5T2
        • Dr. Stephen S. Chow Medicine Professional Corporation
      • Waterloo, Ontario, Kanada, N2T 0C1
        • Clinical Research Solutions Incorporated
  • Litva
    • Kaunas County
      • Kaunas, Kaunas County, Litva, LT-49449
        • Saules seimos medicinos centras
  • Lotyšsko
      • Riga, Lotyšsko
        • P.Stradina Clinical University Hospital
    • Ogre
      • Ogre, Ogre, Lotyšsko
        • Dace Teterovska - Doctor's Practice
  • Malajsie
    • Kelantan
      • Kota Bharu, Kelantan, Malajsie, 15586
        • Hospital Raja Perempuan Zainab II
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malajsie, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malajsie, 59100
        • University Malaya Medical Centre
    • Perak
      • Ipoh, Perak, Malajsie, 30450
        • Hospital Raja Permaisuri Bainun
      • Seri Manjung, Perak, Malajsie, 32400
        • Hospital Seri Manjung
  • Maďarsko
      • Budapest, Maďarsko, 1083
        • Semmelweis Egyetem
      • Budapest, Maďarsko, 1204
        • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
      • Kaposvár, Maďarsko, H-7400
        • Somogy Megyei Kaposi Mór Oktató Kórház
    • Baranya
      • Pécs, Baranya, Maďarsko, 7624
        • Coromed-Smo Kft.
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Maďarsko, 3530
        • IPR Hungary Kft.
    • Csongrád megye
      • Szeged, Csongrád megye, Maďarsko, 6725
        • Sonocor Egészségügyi Szolgáltató Kft.
    • Győr-Moson-Sopron
      • Mosonmagyaróvár, Győr-Moson-Sopron, Maďarsko, 7624
        • TaNa Med Kft
    • Heves County
      • Hatvan, Heves County, Maďarsko, H-3000
        • BKS Research
    • Pest County
      • Kistarcsa, Pest County, Maďarsko, 2143
        • Kistarcsai Flor Ferenc Korhaz
    • Veszprém City
      • Balatonfüred, Veszprém City, Maďarsko, 8230
        • DRC Gyógyszervizsgáló Központ Kft.
  • Německo
      • Berlin, Německo, 12203
        • Charité - Universitätsmedizin Berlin
      • Berlin, Německo, 10117
        • Charité- Universitätsmedizin Berlin
      • Hanover, Německo, 30625
        • Medizinische Hochschule Hannover
      • Jena, Německo, 07747
        • Universitätsklinikum Jena
    • Baden-Wurttemberg
      • Villingen-Schwenningen, Baden-Wurttemberg, Německo, 78052
        • Nephrologisches Zentrum Villingen-Schwenningen
    • North Rhine-Westphalia
      • Dortmund, North Rhine-Westphalia, Německo, 44137
        • Diabeteszentrum DO
      • Düsseldorf, North Rhine-Westphalia, Německo, 23538
        • DaVita Clinical Research Germany GmbH
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Německo, 55131
        • Universitätsklinikum Mainz
  • Polsko
      • Katowice, Polsko, 40-040
        • Synexus Polska Sp. z o.o.
      • Lodz, Polsko, 90127
        • Synexus Polska Sp. z. o.o.
      • Lodz, Polsko, 92-213
        • SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
      • Lublin, Polsko, 20954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Poznan, Polsko, 60-702
        • Synexus Polska Sp. z o.o.
      • Warsaw, Polsko, 02-672
        • Synexus Polska Sp. z o.o.
      • Wroclaw, Polsko, 51-685
        • WroMedica I. Bielicka, A. Strzalkowska s.c.
    • Kuyavian-Pomeranian Voivodeship
      • Grudziądz, Kuyavian-Pomeranian Voivodeship, Polsko, 86-300
        • NZOZ Euromedica Sp. z o.o.
    • Lódzkie
      • Lodz, Lódzkie, Polsko, 94-074
        • Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
  • Spojené státy
    • Alabama
      • Foley, Alabama, Spojené státy, 36535
        • G & L Research, LLC
      • Huntsville, Alabama, Spojené státy, 35805
        • Apogee Clinical Research, LLC
    • Arizona
      • Mesa, Arizona, Spojené státy, 85210
        • Aventiv Research, Inc
    • California
      • Beverly Hills, California, Spojené státy, 90211-2285
        • National Heart Institute
      • Granada Hills, California, Spojené státy, 91344
        • Amicis Research Center
      • Granada Hills, California, Spojené státy, 91324
        • Amicis Research Center (Valencia)
      • Lancaster, California, Spojené státy, 93534
        • Amicis Research Center
      • Northridge, California, Spojené státy, 91325
        • Renal Consultants Medical Group - Granada Hills
      • South Gate, California, Spojené státy, 90280
        • United Clinical Research and Innovations
      • Vacaville, California, Spojené státy, 95687-3557
        • Solano Kidney Care
      • Victorville, California, Spojené státy, 92392
        • Desert Cities Dialysis - Amethyst
      • Victorville, California, Spojené státy, 92395
        • Kidney and Hypertension Center
    • Connecticut
      • Bloomfield, Connecticut, Spojené státy, 06002
        • Davita Clinical Research-Hartford
    • Florida
      • Bradenton, Florida, Spojené státy, 34208
        • Synergy Healthcare
      • Miami, Florida, Spojené státy, 33155
        • Allied Biomedical Research Institute
      • Miami, Florida, Spojené státy, 33126
        • LCC Medical Research
      • Miami, Florida, Spojené státy, 33032-8225
        • Homestead Associates in Research, Inc
      • Miami, Florida, Spojené státy, 33126-3422
        • Total Research Group
      • Miami, Florida, Spojené státy, 33144
        • Oceane 7 Medical&Research Center, Inc.
      • Miami, Florida, Spojené státy, 33166
        • South Florida Research Phase I-Iv, Inc.
      • Miami Lakes, Florida, Spojené státy, 33014
        • Inpatient Research Clinic, LLC
      • Miami Lakes, Florida, Spojené státy, 33014-5602
        • San Marcus Research Clinic, Inc.
      • Naples, Florida, Spojené státy, 34104
        • New Generation Of Medical Research
      • Ocala, Florida, Spojené státy, 34471
        • Sarkis Clinical
      • Orlando, Florida, Spojené státy, 32808
        • Omega Research Orlando, LLC
      • Tampa, Florida, Spojené státy, 33603
        • Genesis Clinical Research
      • Tampa, Florida, Spojené státy, 33604
        • Santos Research Center CORP
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30342
        • Fides Clinical Research
      • Augusta, Georgia, Spojené státy, 30904
        • Southeastern Clinical Research Institute, LLC
      • Columbus, Georgia, Spojené státy, 31904-3650
        • Columbus Associates LLC
      • Macon, Georgia, Spojené státy, 31201-6863
        • Central Georgia Kidney Specialists
    • Illinois
      • Gurney, Illinois, Spojené státy, 60031
        • Clinical Investigation Specialists, Inc.
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital (MGH) - Renal Associates Clinic
    • Minnesota
      • Edina, Minnesota, Spojené státy, 55435-2129
        • InterMed Consultants
    • Missouri
      • Hazelwood, Missouri, Spojené státy, 63042
        • Healthcare Research Network
      • Kansas City, Missouri, Spojené státy, 64111-5964
        • Clinical Research Consultants
      • St Louis, Missouri, Spojené státy, 63136-6111
        • St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89102-1682
        • Healor Primary Care /CCT Research
      • Las Vegas, Nevada, Spojené státy, 89128
        • DaVita Clinical Research (Nevada)
    • New York
      • Jamaica, New York, Spojené státy, 11432
        • NYC Health + Hospitals / Queens - Diabetes Center of Excellence
      • Ridgewood, New York, Spojené státy, 11385
        • Mattoo & Bhat Medical Associates, PC
      • The Bronx, New York, Spojené státy, 10461-1900
        • Albert Einstein's College of Medicine
      • The Bronx, New York, Spojené státy, 10461-2710
        • Kidney Medical Associates, PLLC
    • North Carolina
      • Asheville, North Carolina, Spojené státy, 28801-4104
        • Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville
      • Greenville, North Carolina, Spojené státy, 27834
        • Physicians East, PA
      • Jacksonville, North Carolina, Spojené státy, 28546
        • Eastern Nephrology Associates - Jacksonville
      • New Bern, North Carolina, Spojené státy, 28562-5200
        • Eastern Nephrology Associates - New Bern
      • Raleigh, North Carolina, Spojené státy, 27609-7511
        • North Carolina Nephrology P.A.
      • Winston-Salem, North Carolina, Spojené státy, 27103-7108
        • Brookview Hills Research Associates, LLC
    • Ohio
      • Dayton, Ohio, Spojené státy, 45439
        • Providence Health Partners-Center for Clinical Research
    • South Carolina
      • Columbia, South Carolina, Spojené státy, 29203-6476
        • Columbia Nephrology Associates, PA
    • Tennessee
      • Knoxville, Tennessee, Spojené státy, 37923-3624
        • Knoxville Kidney Center, PLLC
    • Texas
      • Austin, Texas, Spojené státy, 78503
        • Gamma Clinical Research Institute
      • El Paso, Texas, Spojené státy, 79925
        • Davita Clinical Research El Paso
      • El Paso, Texas, Spojené státy, 79935
        • Kidney Consultants of El Paso, P.A.
      • Houston, Texas, Spojené státy, 77099
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, Spojené státy, 77004
        • DaVita Clinical Research Houston
      • San Antonio, Texas, Spojené státy, 78251
        • DaVita Clinical Research
      • San Antonio, Texas, Spojené státy, 78212-4738
        • Clinical Advancement Center, PLLC
      • San Antonio, Texas, Spojené státy, 78229-3342
        • Urology San Antonio - North Central
      • The Woodlands, Texas, Spojené státy, 77384
        • Kidney Specialists of North Houston, PLLC
    • Virginia
      • Norfolk, Virginia, Spojené státy, 23502
        • Davita Norfolk Square
      • Richmond, Virginia, Spojené státy, 23219
        • Dominion Medical Associates, Inc.
    • Wisconsin
      • Kenosha, Wisconsin, Spojené státy, 53142
        • Clinical Investigation Specialists
      • Wauwatosa, Wisconsin, Spojené státy, 53226
        • Milwaukee Nephrologists, SC (Rich)
  • Srbsko
      • Belgrade, Srbsko, 11000
        • Military Medical Academy
      • Belgrade, Srbsko, 11000
        • Zvezdara University Medical Center
      • Belgrade, Srbsko
        • MSB General hospital - Clinical Research Center
      • Kragujevac, Srbsko, 33126-3422
        • Clinical Center Kragujevac
    • Belgrade
      • Zemun, Belgrade, Srbsko, 11080
        • Clinical Hospital Centre Zemun
    • Nišavski Okrug
      • Niš, Nišavski Okrug, Srbsko, 18000
        • Clinical Centre Nis
    • Vojvodina
      • Novi Sad, Vojvodina, Srbsko, 21000
        • Clinical Center Vojvodina
  • Tchaj-wan
      • Taichung, Tchaj-wan, 406
        • China Medical University Hospital - Nephrology - Taichung
      • Taipei, Tchaj-wan, 110
        • Taipei Medical University - Shuang Ho Hospital - Nephrology
      • Taoyuan, Tchaj-wan, 33305
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology
    • Taichung Municipality
      • Taichung, Taichung Municipality, Tchaj-wan, 40705
        • Taichung Veterans General Hospital - Nephrology
    • Taipei Special Muncipality
      • Taipei, Taipei Special Muncipality, Tchaj-wan, 10002
        • National Taiwan University Hospital - Nephrology
  • Česko
      • Prague, Česko, 140 21
        • IKEM
      • Prague, Česko, 160 00
        • Alaron s.r.o.
    • Praha 4
      • Prague, Praha 4, Česko, 149 00
        • Nefrologie s.r.o.
    • Třebíč
      • Třebíč, Třebíč, Česko, 674 01
        • Nemocnice Trebic, p.o.
  • Čína
      • Chongqing, Čína, 400038
        • The Southwest Hospital of AMU
      • Shanghai, Čína, 200233
        • Shanghai Sixth People's Hospital
      • Tianjin, Čína, 300052
        • Tianjin Medical University General Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, Čína, 100029
        • China-Japan Friendship Hospital
      • Beijing, Beijing Municipality, Čína, 100730
        • Beijing Hospital
      • Beijing, Beijing Municipality, Čína, 100020
        • Beijing Chao-Yang Hospital, Capital Medical University
      • Beijing, Beijing Municipality, Čína, 100029
        • Beijing An Zhen Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, Čína, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, Čína, 361003
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, Fujian, Čína, 361004
        • Zhongshan Hospital Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, Čína, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, Čína, 510180
        • Guangzhou First People's Hospital - Nephrology
      • Guangzhou, Guangdong, Čína, 510655
        • The Third Affiliated Hospital, Sun Yat-sen University
    • Guangxi
      • Nanning, Guangxi, Čína, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology
    • Guizhou
      • Guiyang, Guizhou, Čína, 550004
        • The Affliated Hospital of Guizhou Medical University
    • Hebei
      • Shijiazhuang, Hebei, Čína, 50004
        • The Second Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, Čína
        • The First Affiliated Hospital of Zhengzhou University (East Compus)
    • Hubei
      • Wuhan, Hubei, Čína
        • The Central Hospital of Wuhan
    • Hunan
      • Changsha, Hunan, Čína, 410011
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, Čína, 410013
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, Čína, 210029
        • Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University
      • Wuxi, Jiangsu, Čína, 214023
        • Wuxi People's Hospital
    • Nei Mongol (mn)
      • Baotou, Nei Mongol (mn), Čína, 014010
        • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    • Ningxia
      • Yinchuan, Ningxia, Čína, 750004
        • General Hospital of Ningxia Medical University
    • Shaanxi
      • Xi'an, Shaanxi, Čína, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Jinan, Shandong, Čína
        • Shandong Provincial Hospital
      • Yantai, Shandong, Čína, 264000
        • Yantai Yuhuangding Hospital(Base Cpmpus)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200000
        • Shanghai General Hospital
    • Sichuan
      • Chengdu, Sichuan, Čína, 610072
        • Sichuan Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, Čína
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Čína
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, Čína
        • Zhejiang Hospital
      • Jinhua, Zhejiang, Čína, 321000
        • Jinhua Central Hospital
      • Wenzhou, Zhejiang, Čína, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Španělsko
      • Barcelona, Španělsko, 8023
        • Hospital Quironsalud Barcelona
      • Barcelona, Španělsko, 08025
        • FUNDACION PUIGVERT - Nephrology Department
      • Barcelona, Španělsko, 8035
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Španělsko, 8003
        • Hospital del Mar
      • Granada, Španělsko, 18014
        • Hospital Universitario Virgen de las Nieves
      • Lugo, Španělsko, 27880
        • Hospital público da Mariña
      • Lugo, Španělsko, 27880
        • Hospital Ribera Polusa
      • Madrid, Španělsko, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Valencia, Španělsko, 46026
        • Hospital Universitario Y Politécnico La Fe
    • Valenciana, Comunidad
      • Valencia, Valenciana, Comunidad, Španělsko, 46014
        • Consorcio Hospital General Universitario de Valencia

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Body mass index (BMI) must be ≥19 to <45 kg/m^2 at the Screening Visit

  • Participant must have uncontrolled hypertension defined as meeting both of the following criteria:

    • The participant has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period
    • The participant is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3)

  • The participant must have Stage 3b (eGFR [EPI] ≥30 and ≤44 mL/min/1.73 m^2) or Stage 4 (eGFR [EPI] ≥15 and <30 mL/min/1.73 m^2) CKD.

Exclusion Criteria:

  • Participant has a resting seated trough cuff SBP ≥180 mm Hg at the Screening Visit (Visit 1) or at the start (Visit 2) or end (Visit 3) of the Run-In Period
  • Participant has a serum potassium level >4.8 mmol/L during the Screening or Run-In Periods
  • Participant has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1)
  • Participant has been hospitalized for hyperkalemia within the 3 months before the Randomization Visit (Visit 3)
  • Participant was not compliant with taking placebo during the Run-in Period or participant was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3)
  • Participant has taken an mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1)
  • Participant has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1)
  • Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3)
  • Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1).
  • Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo

Open-label Placebo Run-In Period: All eligible participants will receive matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period.

Double-blind Treatment Period: All eligible participants will receive matching placebo, from week 2 thru week 24 during the Double-blind treatment Period

Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period

Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52.

Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.
Lék: Placebo

Participants will orally receive placebo matching to KBP-5074 tablets QD.
Experimentální: KBP-5074

Open-label Placebo Run-In period: All eligible participants will receive matching placebo, for approximately 2 weeks during the Open-label placebo Run-In period.

Double-blind Treatment Period: All eligible participants will receive KBP-5074, from week 2 thru week 24 during the Double-blind Treatment Period

Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period

Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52.

Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.
Lék: KBP-5074

Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Seated Trough Cuff Systolic Blood Pressure (SBP) From Baseline to Week 12
Časové okno: 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, was evaluated.
From baseline to Week 12
Change in Seated Trough Cuff SBP From Week 48 to Week 52
Časové okno: 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, was evaluated.
From Week 48 to Week 52

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Seated Trough Cuff SBP From Baseline to Week 24
Časové okno: From baseline to Week 24

Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, were evaluated.
From baseline to Week 24
Changes in Seated Trough Cuff Diastolic Blood Pressure (DBP) From Baseline to Week 12
Časové okno: From baseline to Week 12

Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated.
From baseline to Week 12
Changes in Urinary Albumin: Creatinine Ratio (UACR) From Baseline to Week 12 for Participants With UACR ≥30 mg/g at Baseline
Časové okno: From baseline to Week 12

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline, was evaluated.
From baseline to Week 12
Percentage Changes in UACR From Baseline to Week 12 and Week 24 for Participants With UACR ≥30 mg/g at Baseline
Časové okno: From baseline to Week 12 and Week 24

Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g at baseline, was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From baseline to Week 12 and Week 24
Changes in Seated Trough Cuff Diastolic Blood Pressure (DBP) From Baseline to Week 24
Časové okno: From baseline to Week 24

Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP was evaluated.
From baseline to Week 24
Changes in Seated Trough Cuff DBP From Baseline to Week 48
Časové okno: From baseline to Week 48

Effect of KBP-5074 on DBP by assessing change in seated trough cuff SBP was evaluated.
From baseline to Week 48
Changes in Seated Trough Cuff SBP From Baseline to Week 48
Časové okno: From baseline to Week 48

Effect of KBP-5074 on SBP by assessing change in seated trough cuff SBP was evaluated.
From baseline to Week 48
Changes in UACR From Baseline to Week 24 for Participants With UACR ≥30 mg/g at Baseline
Časové okno: From baseline to Week 24

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline was evaluated.
From baseline to Week 24
Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Macroalbuminuria
Časové okno: 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) at baseline was 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 in Participants With Macroalbuminuria
Časové okno: 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) at baseline was evaluated.
From baseline to Week 12, Week 24, and Week 48
Change in Seated Trough Cuff DBP From Week 48 to Week 52
Časové okno: From Week 48 to Week 52

Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP was evaluated.
From Week 48 to Week 52
Change in UACR From Week 48 to Week 52 for Participants With UACR ≥30 mg/g at Baseline
Časové okno: Week 48 to Week 52

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
Week 48 to Week 52
Percentage Change in UACR From Week 48 to Week 52 in Participants With UACR ≥30 mg/g at Baseline
Časové okno: 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 was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From Week 48 to Week 52
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Until end of study (EOS) (Week 56) or Unscheduled visit or end of treatment or early termination (up to 32 months)

The safety and tolerability of KBP-5074 was evaluated.

A treatment emergent adverse event (TEAE) was defined as any AE with onset during or after first dose and before 4 weeks after last dose of study drug, or any preexisting AE/condition that worsened during this period.

Selected TEAEs include Hyperkalemia, Hypertension, Hypotension, and eGFR Decrease.
Until end of study (EOS) (Week 56) or Unscheduled visit or end of treatment or early termination (up to 32 months)
Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Microalbuminuria
Časové okno: From baseline to Week 12, Week 24, and Week 48

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was 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 in Participants With Microalbuminuria
Časové okno: From baseline to Week 12, Week 24, and Week 48

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline was evaluated.
From baseline to Week 12, Week 24, and Week 48
Change in UACR From Week 48 to Week 52 in Participants With Microalbuminuria
Časové okno: From Week 48 to Week 52

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From Week 48 to Week 52
Percentage Change in UACR From Week 48 to Week 52 in Participants With Microalbuminuria
Časové okno: From Week 48 to Week 52

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From Week 48 to Week 52
Change in UACR From Week 48 to Week 52 in Participants With Macroalbuminuria
Časové okno: From Week 48 to Week 52

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From Week 48 to Week 52
Percentage Change in UACR From Week 48 to Week 52 in Participants With Macroalbuminuria
Časové okno: From Week 48 to Week 52

Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.
From Week 48 to Week 52

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novo Nordisk A/S

Spolupracovníci

KBP Biosciences

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. listopadu 2021

Primární dokončení (Aktuální)

30. ledna 2024

Dokončení studie (Aktuální)

10. července 2024

Termíny zápisu do studia

První předloženo

7. července 2021

První předloženo, které splnilo kritéria kontroly kvality

7. července 2021

První zveřejněno (Aktuální)

20. července 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. října 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KBP5074-3-001
  • 2021-003636-88 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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