Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
NCT ID: NCT04968184
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
652 participants
INTERVENTIONAL
2021-11-05
2024-07-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo
Participants will orally receive placebo matching to KBP-5074 tablets QD.
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.
KBP-5074
Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.
Interventions
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Placebo
Participants will orally receive placebo matching to KBP-5074 tablets QD.
KBP-5074
Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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KBP Biosciences
INDUSTRY
Responsible Party
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Locations
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G & L Research, LLC
Foley, Alabama, United States
Apogee Clinical Research, LLC
Huntsville, Alabama, United States
Aventiv Research, Inc
Mesa, Arizona, United States
National Heart Institute
Beverly Hills, California, United States
Amicis Research Center (Valencia)
Granada Hills, California, United States
Amicis Research Center
Granada Hills, California, United States
Amicis Research Center
Lancaster, California, United States
Renal Consultants Medical Group - Granada Hills
Northridge, California, United States
United Clinical Research and Innovations
South Gate, California, United States
Solano Kidney Care
Vacaville, California, United States
Desert Cities Dialysis - Amethyst
Victorville, California, United States
Kidney and Hypertension Center
Victorville, California, United States
Davita Clinical Research-Hartford
Bloomfield, Connecticut, United States
Synergy Healthcare
Bradenton, Florida, United States
Homestead Associates in Research, Inc
Miami, Florida, United States
Total Research Group
Miami, Florida, United States
LCC Medical Research
Miami, Florida, United States
Oceane 7 Medical&Research Center, Inc.
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
South Florida Research Phase I-Iv, Inc.
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Inpatient Research Clinic, LLC
Miami Lakes, Florida, United States
New Generation Of Medical Research
Naples, Florida, United States
Sarkis Clinical
Ocala, Florida, United States
Omega Research Orlando, LLC
Orlando, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Santos Research Center CORP
Tampa, Florida, United States
Fides Clinical Research
Atlanta, Georgia, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States
Columbus Associates LLC
Columbus, Georgia, United States
Central Georgia Kidney Specialists
Macon, Georgia, United States
Clinical Investigation Specialists, Inc.
Gurney, Illinois, United States
Massachusetts General Hospital (MGH) - Renal Associates Clinic
Boston, Massachusetts, United States
InterMed Consultants
Edina, Minnesota, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Clinical Research Consultants
Kansas City, Missouri, United States
St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office
St Louis, Missouri, United States
Healor Primary Care /CCT Research
Las Vegas, Nevada, United States
DaVita Clinical Research (Nevada)
Las Vegas, Nevada, United States
NYC Health + Hospitals / Queens - Diabetes Center of Excellence
Jamaica, New York, United States
Mattoo & Bhat Medical Associates, PC
Ridgewood, New York, United States
Albert Einstein's College of Medicine
The Bronx, New York, United States
Kidney Medical Associates, PLLC
The Bronx, New York, United States
Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville
Asheville, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
Eastern Nephrology Associates - Jacksonville
Jacksonville, North Carolina, United States
Eastern Nephrology Associates - New Bern
New Bern, North Carolina, United States
North Carolina Nephrology P.A.
Raleigh, North Carolina, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Gamma Clinical Research Institute
Austin, Texas, United States
Davita Clinical Research El Paso
El Paso, Texas, United States
Kidney Consultants of El Paso, P.A.
El Paso, Texas, United States
DaVita Clinical Research Houston
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Urology San Antonio - North Central
San Antonio, Texas, United States
DaVita Clinical Research
San Antonio, Texas, United States
Kidney Specialists of North Houston, PLLC
The Woodlands, Texas, United States
Davita Norfolk Square
Norfolk, Virginia, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, United States
Clinical Investigation Specialists
Kenosha, Wisconsin, United States
Milwaukee Nephrologists, SC (Rich)
Wauwatosa, Wisconsin, United States
Renal Research
Gosford, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Clinical Center University of Sarajevo
Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology
Banja Luka, Republika Srpska, Bosnia and Herzegovina
The University Hospital Foca
Foča, Republika Srpska, Bosnia and Herzegovina
General Hospital Gradiska
Gradiška, Republika Srpska, Bosnia and Herzegovina
General hospital Trebinje - Gastroenterology
Trebinje, Republika Srpska, Bosnia and Herzegovina
General Hospital Tesanj
Tešanj, Zeničko-dobojski Kanton, Bosnia and Herzegovina
5 th MHAT
Sofia, Sofia-Grad, Bulgaria
Medical Center Excelsior
Sofia, Sofia-Grad, Bulgaria
UMHAT St. Ekaterina
Sofia, Sofia-Grad, Bulgaria
Comac Medical Ltd
Sofia, Sofia-Grad, Bulgaria
Mhat Dr.Tota Venkova
Gabrovo, , Bulgaria
Medical Center Hera EOOD
Montana, , Bulgaria
UMHAT Kaspela
Plovdiv, , Bulgaria
Medical Center "Teodora"
Rousse, , Bulgaria
DCC 22 - Sofia
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Medical Center ''Synexus Sofia'' EOOD
Sofia, , Bulgaria
University Hospital of Active Treatment Prof. Stoyan Kirkovich
Stara Zagora, , Bulgaria
MHAT"Sv.Anna-Varna"AD
Varna, , Bulgaria
Dr. Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, Canada
Clinical Research Solutions Incorporated
Waterloo, Ontario, Canada
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Guangzhou First People's Hospital - Nephrology
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology
Nanning, Guangxi, China
The Affliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 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, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Nei Mongol (mn), China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
Yantai Yuhuangding Hospital(Base Cpmpus)
Yantai, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences
Chengdu, Sichuan, 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, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Southwest Hospital of AMU
Chongqing, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
University Hospital Centre Zagreb
Zagreb, City of Zagreb, Croatia
Opca bolnica Vinkovci
Vinkovci, Osjecko-baranjska Županija, Croatia
University Hospital Center Split
Split, , Croatia
Nefrologie s.r.o.
Prague, Praha 4, Czechia
Nemocnice Trebic, p.o.
Třebíč, Třebíč, Czechia
IKEM
Prague, , Czechia
Alaron s.r.o.
Prague, , Czechia
LTD "High technology hospital MEDCENTER"
Batumi, Adjara, Georgia
Ltd Marnecor
Marneuli, Kvemo Kartli, Georgia
Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital
Gori, Shida Kartli, Georgia
JSC "Evex Hospitals'
Batumi, , Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
"Pineo Medical Ecosystem"LTD
Tbilisi, , Georgia
JSC German Clinic
Tbilisi, , Georgia
National Center of Urology Named after Laur Managadze
Tbilisi, , Georgia
Bokhua Memorial Cardiovascular Centre
Tbilisi, , Georgia
Emergency Cardiology Center named by acad. G. Chapidze
Tbilisi, , Georgia
J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
Tbilisi, , Georgia
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Diabeteszentrum DO
Dortmund, North Rhine-Westphalia, Germany
DaVita Clinical Research Germany GmbH
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Mainz
Mainz, Rhineland-Palatinate, Germany
Charité- Universitätsmedizin Berlin
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
Queen Mary Hospital - Medicine
Hong Kong, , Hong Kong
Tung Wah Hospital
Hong Kong, , Hong Kong
Coromed-Smo Kft.
Pécs, Baranya, Hungary
IPR Hungary Kft.
Miskolc, Borsod-Abauj Zemplen county, Hungary
Sonocor Egészségügyi Szolgáltató Kft.
Szeged, Csongrád megye, Hungary
TaNa Med Kft
Mosonmagyaróvár, Győr-Moson-Sopron, Hungary
BKS Research
Hatvan, Heves County, Hungary
Kistarcsai Flor Ferenc Korhaz
Kistarcsa Hungary, Pest County, Hungary
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, Veszprém City, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Rabin Medical Center
Petah Tikwa, Central District, Israel
Nazareth Hospital EMMS
Nazareth, Northern District, Israel
Dace Teterovska - Doctor's Practice
Ogre, Ogre, Latvia
P.Stradina Clinical University Hospital
Riga, , Latvia
Saules seimos medicinos centras
Kaunas, Kaunas County, Lithuania
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Seri Manjung
Seri Manjung, Perak, Malaysia
NZOZ Euromedica Sp. z o.o.
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Lodz, Lódzkie, Poland
Synexus Polska Sp. z o.o.
Katowice, , Poland
Synexus Polska Sp. z. o.o.
Lodz, , Poland
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Synexus Polska Sp. z o.o.
Poznan, , Poland
Synexus Polska Sp. z o.o.
Warsaw, , Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , Poland
Clinical Hospital Centre Zemun
Zemun, Belgrade, Serbia
Clinical Centre Nis
Niš, Nišavski Okrug, Serbia
Clinical Center Vojvodina
Novi Sad, Vojvodina, Serbia
Military Medical Academy
Belgrade, , Serbia
Zvezdara University Medical Center
Belgrade, , Serbia
MSB General hospital - Clinical Research Center
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Iatros International
Bloemfontein, Free State, South Africa
Charlotte Maxeke Johannesburg Hospital
Soweto, Gauteng, South Africa
Office of Gulam Hoosain Vally
Durban, KwaZulu-Natal, South Africa
Tiervlei Trial Centre
Bellville, Cape Town, Western Cape, South Africa
Dr J.M. Engelbrecht Trial Site
Somerset West, Western Cape, South Africa
Chungnam National University Hospital - Nephrology
Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], South Korea
National Health Insurance Service Ilsan Hospital - Nephrology
Goyang-si, Gyeonggido [Kyonggi-do], South Korea
Seoul National University Hospital - Nephrology
Jongno-gu, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Samsung Medical Center - Nephrology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
Hospital público da Mariña
Burela de Cabo, Lugo, Spain
Hospital Ribera Polusa
Burela de Cabo, Lugo, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Valenciana, Comunidad, Spain
FUNDACION PUIGVERT - Nephrology Department
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario Y Politécnico La Fe
Valencia, , Spain
Taichung Veterans General Hospital - Nephrology
Taichung, Taichung Municipality, Taiwan
National Taiwan University Hospital - Nephrology
Taipei, Taipei Special Muncipality, Taiwan
China Medical University Hospital - Nephrology - Taichung
Taichung, , Taiwan
Taipei Medical University - Shuang Ho Hospital - Nephrology
Taipei, , Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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KBP5074-3-001
Identifier Type: -
Identifier Source: org_study_id
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