New hope for Tough-to-Treat hypertension in kidney patients?

NCT ID NCT04968184

Disease control Sponsor: KBP Biosciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a drug called KBP-5074 in 652 adults with moderate-to-severe chronic kidney disease and high blood pressure that was not controlled by at least two other medications. Participants received either KBP-5074 or a placebo daily for up to 52 weeks to see if the drug could safely lower blood pressure. The trial was terminated early, so final conclusions are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KBP-5074 (a mineralocorticoid receptor antagonist)
What this could lead to: If successful, this could offer a new treatment option to lower blood pressure in people with advanced kidney disease who have not responded to other medications.
What could go wrong: The trial was terminated early, so results may be incomplete. It is unclear if KBP-5074 is safe or effective long-term for this patient group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

652 people

The number who actually took part.

Started

Nov 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases

Contacts and locations

Locations

"Pineo Medical Ecosystem"LTD

Tbilisi, 0114, Georgia
5 th MHAT

Sofia, Sofia-Grad, 1233, Bulgaria
Alaron s.r.o.

Prague, 160 00, Czechia
Albert Einstein's College of Medicine

The Bronx, New York, 10461-1900, United States
Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia
Allied Biomedical Research Institute

Miami, Florida, 33155, United States
Amicis Research Center

Granada Hills, California, 91344, United States
Amicis Research Center

Lancaster, California, 93534, United States
Amicis Research Center (Valencia)

Granada Hills, California, 91324, United States
Apogee Clinical Research, LLC

Huntsville, Alabama, 35805, United States
Austin Hospital

Heidelberg, Victoria, 3084, Australia
Aventiv Research, Inc

Mesa, Arizona, 85210, United States
BKS Research

Hatvan, Heves County, H-3000, Hungary
Beijing An Zhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China
Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China
Beijing Hospital

Beijing, Beijing Municipality, 100730, China
Bokhua Memorial Cardiovascular Centre

Tbilisi, 0159, Georgia
Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, 27103-7108, United States
Central Georgia Kidney Specialists

Macon, Georgia, 31201-6863, United States
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology

Taoyuan, 33305, Taiwan
Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany
Charité- Universitätsmedizin Berlin

Berlin, 10117, Germany
Charlotte Maxeke Johannesburg Hospital

Soweto, Gauteng, 2193, South Africa
China Medical University Hospital - Nephrology - Taichung

Taichung, 406, Taiwan
China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China
Chungnam National University Hospital - Nephrology

Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], 35015, South Korea
Clinical Advancement Center, PLLC

San Antonio, Texas, 78212-4738, United States
Clinical Center Kragujevac

Kragujevac, 33126-3422, Serbia
Clinical Center University of Sarajevo

Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina
Clinical Center Vojvodina

Novi Sad, Vojvodina, 21000, Serbia
Clinical Centre Nis

Niš, Nišavski Okrug, 18000, Serbia
Clinical Hospital Centre Zemun

Zemun, Belgrade, 11080, Serbia
Clinical Investigation Specialists

Kenosha, Wisconsin, 53142, United States
Clinical Investigation Specialists, Inc.

Gurney, Illinois, 60031, United States
Clinical Research Consultants

Kansas City, Missouri, 64111-5964, United States
Clinical Research Solutions Incorporated

Waterloo, Ontario, N2T 0C1, Canada
Columbia Nephrology Associates, PA

Columbia, South Carolina, 29203-6476, United States
Columbus Associates LLC

Columbus, Georgia, 31904-3650, United States
Comac Medical Ltd

Sofia, Sofia-Grad, 1612, Bulgaria
Consorcio Hospital General Universitario de Valencia

Valencia, Valenciana, Comunidad, 46014, Spain
Coromed-Smo Kft.

Pécs, Baranya, 7624, Hungary
DCC 22 - Sofia

Sofia, 1113, Bulgaria
DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, Veszprém City, 8230, Hungary
DaVita Clinical Research

San Antonio, Texas, 78251, United States
DaVita Clinical Research (Nevada)

Las Vegas, Nevada, 89128, United States
DaVita Clinical Research Germany GmbH

Düsseldorf, North Rhine-Westphalia, 23538, Germany
DaVita Clinical Research Houston

Houston, Texas, 77004, United States
Dace Teterovska - Doctor's Practice

Ogre, Ogre, Latvia
Davita Clinical Research El Paso

El Paso, Texas, 79925, United States
Davita Clinical Research-Hartford

Bloomfield, Connecticut, 06002, United States
Davita Norfolk Square

Norfolk, Virginia, 23502, United States
Desert Cities Dialysis - Amethyst

Victorville, California, 92392, United States
Diabeteszentrum DO

Dortmund, North Rhine-Westphalia, 44137, Germany
Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States
Dr J.M. Engelbrecht Trial Site

Somerset West, Western Cape, 7130, South Africa
Dr. Stephen S. Chow Medicine Professional Corporation

Toronto, Ontario, M4C 5T2, Canada
Eastern Nephrology Associates - Jacksonville

Jacksonville, North Carolina, 28546, United States
Eastern Nephrology Associates - New Bern

New Bern, North Carolina, 28562-5200, United States
Emergency Cardiology Center named by acad. G. Chapidze

Tbilisi, 0159, Georgia
FUNDACION PUIGVERT - Nephrology Department

Barcelona, 08025, Spain
Fides Clinical Research

Atlanta, Georgia, 30342, United States
G & L Research, LLC

Foley, Alabama, 36535, United States
Gamma Clinical Research Institute

Austin, Texas, 78503, United States
Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6273, South Korea
General Hospital Gradiska

Gradiska, Republika Srpska, 78400, Bosnia and Herzegovina
General Hospital Tesanj

Tešanj, Zeničko-dobojski Kanton, 72460, Bosnia and Herzegovina
General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China
General hospital Trebinje - Gastroenterology

Trebinje, Republika Srpska, 89101, Bosnia and Herzegovina
Genesis Clinical Research

Tampa, Florida, 33603, United States
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China
Guangzhou First People's Hospital - Nephrology

Guangzhou, Guangdong, 510180, China
Healor Primary Care /CCT Research

Las Vegas, Nevada, 89102-1682, United States
Healthcare Research Network

Hazelwood, Missouri, 63042, United States
Homestead Associates in Research, Inc

Miami, Florida, 33032-8225, United States
Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia
Hospital Quironsalud Barcelona

Barcelona, 8023, Spain
Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia
Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia
Hospital Ribera Polusa

Burela de Cabo, Lugo, 27880, Spain
Hospital Seri Manjung

Seri Manjung, Perak, 32400, Malaysia
Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain
Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain
Hospital Universitario Y Politécnico La Fe

Valencia, 46026, Spain
Hospital de La Santa Creu i Sant Pau

Barcelona, 8035, Spain
Hospital del Mar

Barcelona, 8003, Spain
Hospital público da Mariña

Burela de Cabo, Lugo, 27880, Spain
IKEM

Prague, 140 21, Czechia
IPR Hungary Kft.

Miskolc, Borsod-Abauj Zemplen county, 3530, Hungary
Iatros International

Bloemfontein, Free State, 9301, South Africa
Inpatient Research Clinic, LLC

Miami Lakes, Florida, 33014, United States
InterMed Consultants

Edina, Minnesota, 55435-2129, United States
J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"

Tbilisi, 0159, Georgia
JSC "Evex Hospitals'

Batumi, 6010, Georgia
JSC German Clinic

Tbilisi, 0119, Georgia
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

Budapest, 1204, Hungary
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China
Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China
Kidney Consultants of El Paso, P.A.

El Paso, Texas, 79935, United States
Kidney Medical Associates, PLLC

The Bronx, New York, 10461-2710, United States
Kidney Specialists of North Houston, PLLC

The Woodlands, Texas, 77384, United States
Kidney and Hypertension Center

Victorville, California, 92395, United States
Kistarcsai Flor Ferenc Korhaz

Kistarcsa Hungary, Pest County, 2143, Hungary
Knoxville Kidney Center, PLLC

Knoxville, Tennessee, 37923-3624, United States
LCC Medical Research

Miami, Florida, 33126, United States
LTD "High technology hospital MEDCENTER"

Batumi, Adjara, 6000, Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia
Ltd Marnecor

Marneuli, Kvemo Kartli, 3000, Georgia
MHAT"Sv.Anna-Varna"AD

Varna, 9002, Bulgaria
MSB General hospital - Clinical Research Center

Belgrade, Serbia
Massachusetts General Hospital (MGH) - Renal Associates Clinic

Boston, Massachusetts, 02114, United States
Mattoo & Bhat Medical Associates, PC

Ridgewood, New York, 11385, United States
Medical Center "Teodora"

Rousse, 7012, Bulgaria
Medical Center ''Synexus Sofia'' EOOD

Sofia, 1784, Bulgaria
Medical Center Excelsior

Sofia, Sofia-Grad, 1407, Bulgaria
Medical Center Hera EOOD

Montana, 3400, Bulgaria
Medical Center Hera EOOD

Sofia, 1510, Bulgaria
Medizinische Hochschule Hannover

Hanover, 30625, Germany
Mhat Dr.Tota Venkova

Gabrovo, 5300, Bulgaria
Military Medical Academy

Belgrade, 11000, Serbia
Milwaukee Nephrologists, SC (Rich)

Wauwatosa, Wisconsin, 53226, United States
Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital

Gori, Shida Kartli, 1400, Georgia
Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville

Asheville, North Carolina, 28801-4104, United States
NYC Health + Hospitals / Queens - Diabetes Center of Excellence

Jamaica, New York, 11432, United States
NZOZ Euromedica Sp. z o.o.

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland
National Center of Urology Named after Laur Managadze

Tbilisi, 0144, Georgia
National Health Insurance Service Ilsan Hospital - Nephrology

Goyang-si, Gyeonggido [Kyonggi-do], 10444, South Korea
National Heart Institute

Beverly Hills, California, 90211-2285, United States
National Taiwan University Hospital - Nephrology

Taipei, Taipei Special Muncipality, 10002, Taiwan
Nazareth Hospital EMMS

Nazareth, Northern District, 16100, Israel
Nefrologie s.r.o.

Prague, Praha 4, 149 00, Czechia
Nemocnice Trebic, p.o.

Třebíč, Třebíč, 674 01, Czechia
Nephrologisches Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany
New Generation Of Medical Research

Naples, Florida, 34104, United States
North Carolina Nephrology P.A.

Raleigh, North Carolina, 27609-7511, United States
Oceane 7 Medical&Research Center, Inc.

Miami, Florida, 33144, United States
Office of Gulam Hoosain Vally

Durban, KwaZulu-Natal, 4001, South Africa
Omega Research Orlando, LLC

Orlando, Florida, 32808, United States
Opca bolnica Vinkovci

Vinkovci, Osjecko-baranjska Županija, 32100, Croatia
P.Stradina Clinical University Hospital

Riga, Latvia
Peking University First Hospital

Beijing, Beijing Municipality, 100034, China
Physicians East, PA

Greenville, North Carolina, 27834, United States
Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States
Providence Health Partners-Center for Clinical Research

Dayton, Ohio, 45439, United States
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer

Lodz, Lódzkie, 94-074, Poland
Queen Mary Hospital - Medicine

Hong Kong, Hong Kong
Rabin Medical Center

Petah Tikwa, Central District, 49100, Israel
Renal Consultants Medical Group - Granada Hills

Northridge, California, 91325, United States
Renal Research

Gosford, New South Wales, 2250, Australia
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, 92-213, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, 20954, Poland
Samsung Medical Center - Nephrology

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351, South Korea
San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014-5602, United States
Santos Research Center CORP

Tampa, Florida, 33604, United States
Sarkis Clinical

Ocala, Florida, 34471, United States
Saules seimos medicinos centras

Kaunas, Kaunas County, LT-49449, Lithuania
Semmelweis Egyetem

Budapest, 1083, Hungary
Seoul National University Hospital - Nephrology

Jongno-gu, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080, South Korea
Shandong Provincial Hospital

Jinan, Shandong, China
Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China
Shanghai Sixth People's Hospital

Shanghai, 200233, China
Sichuan Academy of Medical Sciences

Chengdu, Sichuan, 610072, China
Solano Kidney Care

Vacaville, California, 95687-3557, United States
Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, H-7400, Hungary
Sonocor Egészségügyi Szolgáltató Kft.

Szeged, Csongrád megye, 6725, Hungary
South Florida Research Phase I-Iv, Inc.

Miami, Florida, 33166, United States
Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States
St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office

St Louis, Missouri, 63136-6111, United States
Synergy Healthcare

Bradenton, Florida, 34208, United States
Synexus Polska Sp. z o.o.

Katowice, 40-040, Poland
Synexus Polska Sp. z o.o.

Poznan, 60-702, Poland
Synexus Polska Sp. z o.o.

Warsaw, 02-672, Poland
Synexus Polska Sp. z. o.o.

Lodz, 90127, Poland
TaNa Med Kft

Mosonmagyaróvár, Győr-Moson-Sopron, 7624, Hungary
Taichung Veterans General Hospital - Nephrology

Taichung, Taichung Municipality, 40705, Taiwan
Taipei Medical University - Shuang Ho Hospital - Nephrology

Taipei, 110, Taiwan
The Affliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China
The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591, South Korea
The Central Hospital of Wuhan

Wuhan, Hubei, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Nei Mongol (mn), 014010, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Zhengzhou University (East Compus)

Zhengzhou, Henan, China
The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology

Nanning, Guangxi, 530021, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50004, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The Southwest Hospital of AMU

Chongqing, 400038, China
The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China
The University Hospital Foca

Foca, Republika Srpska, 73300, Bosnia and Herzegovina
Tianjin Medical University General Hospital

Tianjin, 300052, China
Tiervlei Trial Centre

Bellville, Cape Town, Western Cape, 7530, South Africa
Total Research Group

Miami, Florida, 33126-3422, United States
Tung Wah Hospital

Hong Kong, Hong Kong
UMHAT Kaspela

Plovdiv, 4002, Bulgaria
UMHAT St. Ekaterina

Sofia, Sofia-Grad, 1431, Bulgaria
United Clinical Research and Innovations

South Gate, California, 90280, United States
University Hospital Center Split

Split, 21000, Croatia
University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10000, Croatia
University Hospital of Active Treatment Prof. Stoyan Kirkovich

Stara Zagora, 6000, Bulgaria
University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Universitätsklinikum Jena

Jena, 07747, Germany
Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany
Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Urology San Antonio - North Central

San Antonio, Texas, 78229-3342, United States
WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, 51-685, Poland
Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China
Yantai Yuhuangding Hospital(Base Cpmpus)

Yantai, Shandong, 264000, China
Zhejiang Hospital

Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China
Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China
Zvezdara University Medical Center

Belgrade, 11000, Serbia

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