Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD) (Clarion-CKD)

A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Placebo; Drug: KBP-5074

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Placebo; Participants will orally receive placebo matching to KBP-5074 tablets QD.
Experimental: 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.	Drug: KBP-5074; Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: KBP Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Uncontrolled Hypertension; Mineralocorticoid Receptor Antagonist; Randomized withdrawal; Stage 3b/4 chronic kidney disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hypertension; Renal Insufficiency, Chronic; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; KBP-5074
• Other Study ID Numbers: KBP5074-3-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No