AzTrials
AzTrials

Chronic Kidney DiseasesPhase 3Clarion-CKDNCT04968184

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

A Phase 3 study testing KBP-5074 in people with Chronic Kidney Diseases, run by Novo Nordisk A/S at 215 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
KBP-5074
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
666 participants
Where
215 sitesin 22 countries
Study dates
5 Nov 2021to 10 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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).

Trial locations and contacts

215 sites in 22 countries.

215 sites in 22 countries

United States65 sites

  • Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville

    Asheville, North Carolina, 28801-4104

  • Fides Clinical Research

    Atlanta, Georgia, 30342

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30904

  • Gamma Clinical Research Institute

    Austin, Texas, 78503

  • National Heart Institute

    Beverly Hills, California, 90211-2285

  • Davita Clinical Research-Hartford

    Bloomfield, Connecticut, 06002

  • Massachusetts General Hospital (MGH) - Renal Associates Clinic

    Boston, Massachusetts, 02114

  • Synergy Healthcare

    Bradenton, Florida, 34208

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203-6476

  • Columbus Associates LLC

    Columbus, Georgia, 31904-3650

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio, 45439

  • InterMed Consultants

    Edina, Minnesota, 55435-2129

  • Davita Clinical Research El Paso

    El Paso, Texas, 79925

  • Kidney Consultants of El Paso, P.A.

    El Paso, Texas, 79935

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Amicis Research Center (Valencia)

    Granada Hills, California, 91324

  • Amicis Research Center

    Granada Hills, California, 91344

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Clinical Investigation Specialists, Inc.

    Gurney, Illinois, 60031

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • DaVita Clinical Research Houston

    Houston, Texas, 77004

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Apogee Clinical Research, LLC

    Huntsville, Alabama, 35805

  • Eastern Nephrology Associates - Jacksonville

    Jacksonville, North Carolina, 28546

  • NYC Health + Hospitals / Queens - Diabetes Center of Excellence

    Jamaica, New York, 11432

  • Clinical Research Consultants

    Kansas City, Missouri, 64111-5964

  • Clinical Investigation Specialists

    Kenosha, Wisconsin, 53142

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923-3624

  • Amicis Research Center

    Lancaster, California, 93534

  • Healor Primary Care /CCT Research

    Las Vegas, Nevada, 89102-1682

  • DaVita Clinical Research (Nevada)

    Las Vegas, Nevada, 89128

  • Central Georgia Kidney Specialists

    Macon, Georgia, 31201-6863

  • Aventiv Research, Inc

    Mesa, Arizona, 85210

  • Homestead Associates in Research, Inc

    Miami, Florida, 33032-8225

  • Total Research Group

    Miami, Florida, 33126-3422

  • LCC Medical Research

    Miami, Florida, 33126

  • Oceane 7 Medical&Research Center, Inc.

    Miami, Florida, 33144

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • South Florida Research Phase I-Iv, Inc.

    Miami, Florida, 33166

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014-5602

  • Inpatient Research Clinic, LLC

    Miami Lakes, Florida, 33014

  • New Generation Of Medical Research

    Naples, Florida, 34104

  • Eastern Nephrology Associates - New Bern

    New Bern, North Carolina, 28562-5200

  • Davita Norfolk Square

    Norfolk, Virginia, 23502

  • Renal Consultants Medical Group - Granada Hills

    Northridge, California, 91325

  • Sarkis Clinical

    Ocala, Florida, 34471

  • Omega Research Orlando, LLC

    Orlando, Florida, 32808

  • North Carolina Nephrology P.A.

    Raleigh, North Carolina, 27609-7511

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Mattoo & Bhat Medical Associates, PC

    Ridgewood, New York, 11385

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212-4738

  • Urology San Antonio - North Central

    San Antonio, Texas, 78229-3342

  • DaVita Clinical Research

    San Antonio, Texas, 78251

  • United Clinical Research and Innovations

    South Gate, California, 90280

  • St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office

    St Louis, Missouri, 63136-6111

  • Genesis Clinical Research

    Tampa, Florida, 33603

  • Santos Research Center CORP

    Tampa, Florida, 33604

  • Albert Einstein's College of Medicine

    The Bronx, New York, 10461-1900

  • Kidney Medical Associates, PLLC

    The Bronx, New York, 10461-2710

  • Kidney Specialists of North Houston, PLLC

    The Woodlands, Texas, 77384

  • Solano Kidney Care

    Vacaville, California, 95687-3557

  • Desert Cities Dialysis - Amethyst

    Victorville, California, 92392

  • Kidney and Hypertension Center

    Victorville, California, 92395

  • Milwaukee Nephrologists, SC (Rich)

    Wauwatosa, Wisconsin, 53226

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103-7108

Other trials in United States

China35 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Nei Mongol (mn), 014010

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Sichuan Academy of Medical Sciences

    Chengdu, Sichuan, 610072

  • The Southwest Hospital of AMU

    Chongqing, 400038

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Guangzhou First People's Hospital - Nephrology

    Guangzhou, Guangdong, 510180

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • The Affliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Jinhua Central Hospital

    Jinhua, Zhejiang, 321000

  • Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology

    Nanning, Guangxi, 530021

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Sixth People's Hospital

    Shanghai, 200233

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Central Hospital of Wuhan

    Wuhan, Hubei

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • Yantai Yuhuangding Hospital(Base Cpmpus)

    Yantai, Shandong, 264000

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • The First Affiliated Hospital of Zhengzhou University (East Compus)

    Zhengzhou, Henan

Other trials in China

Bulgaria13 sites

  • Mhat Dr.Tota Venkova

    Gabrovo, 5300

  • Medical Center Hera EOOD

    Montana, 3400

  • UMHAT Kaspela

    Plovdiv, 4002

  • Medical Center "Teodora"

    Rousse, 7012

  • 5 th MHAT

    Sofia, Sofia-Grad, 1233

  • Medical Center Excelsior

    Sofia, Sofia-Grad, 1407

  • UMHAT St. Ekaterina

    Sofia, Sofia-Grad, 1431

  • Comac Medical Ltd

    Sofia, Sofia-Grad, 1612

  • DCC 22 - Sofia

    Sofia, 1113

  • Medical Center Hera EOOD

    Sofia, 1510

  • Medical Center ''Synexus Sofia'' EOOD

    Sofia, 1784

  • University Hospital of Active Treatment Prof. Stoyan Kirkovich

    Stara Zagora, 6000

  • MHAT"Sv.Anna-Varna"AD

    Varna, 9002

Other trials in Bulgaria

Georgia12 sites

  • LTD "High technology hospital MEDCENTER"

    Batumi, Adjara, 6000

  • JSC "Evex Hospitals'

    Batumi, 6010

  • Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital

    Gori, Shida Kartli, 1400

  • Ltd Marnecor

    Marneuli, Kvemo Kartli, 3000

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102

  • LTD Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • "Pineo Medical Ecosystem"LTD

    Tbilisi, 0114

  • JSC German Clinic

    Tbilisi, 0119

  • National Center of Urology Named after Laur Managadze

    Tbilisi, 0144

  • Bokhua Memorial Cardiovascular Centre

    Tbilisi, 0159

  • Emergency Cardiology Center named by acad. G. Chapidze

    Tbilisi, 0159

  • J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"

    Tbilisi, 0159

Other trials in Georgia

Hungary10 sites

  • DRC Gyógyszervizsgáló Központ Kft.

    Balatonfüred, Veszprém City, 8230

  • Semmelweis Egyetem

    Budapest, 1083

  • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

    Budapest, 1204

  • BKS Research

    Hatvan, Heves County, H-3000

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, H-7400

  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, Pest County, 2143

  • IPR Hungary Kft.

    Miskolc, Borsod-Abauj Zemplen county, 3530

  • TaNa Med Kft

    Mosonmagyaróvár, Győr-Moson-Sopron, 7624

  • Coromed-Smo Kft.

    Pécs, Baranya, 7624

  • Sonocor Egészségügyi Szolgáltató Kft.

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Spain10 sites

  • FUNDACION PUIGVERT - Nephrology Department

    Barcelona, 08025

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Quironsalud Barcelona

    Barcelona, 8023

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8035

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital público da Mariña

    Lugo, 27880

  • Hospital Ribera Polusa

    Lugo, 27880

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Consorcio Hospital General Universitario de Valencia

    Valencia, Valenciana, Comunidad, 46014

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026

Other trials in Spain

Poland9 sites

  • NZOZ Euromedica Sp. z o.o.

    Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300

  • Synexus Polska Sp. z o.o.

    Katowice, 40-040

  • Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer

    Lodz, Lódzkie, 94-074

  • Synexus Polska Sp. z. o.o.

    Lodz, 90127

  • SP ZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-213

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20954

  • Synexus Polska Sp. z o.o.

    Poznan, 60-702

  • Synexus Polska Sp. z o.o.

    Warsaw, 02-672

  • WroMedica I. Bielicka, A. Strzalkowska s.c.

    Wroclaw, 51-685

Other trials in Poland

Germany8 sites

  • Charité- Universitätsmedizin Berlin

    Berlin, 10117

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Diabeteszentrum DO

    Dortmund, North Rhine-Westphalia, 44137

  • DaVita Clinical Research Germany GmbH

    Düsseldorf, North Rhine-Westphalia, 23538

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Jena

    Jena, 07747

  • Universitätsklinikum Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

Other trials in Germany

Serbia7 sites

  • Military Medical Academy

    Belgrade, 11000

  • Zvezdara University Medical Center

    Belgrade, 11000

  • MSB General hospital - Clinical Research Center

    Belgrade

  • Clinical Center Kragujevac

    Kragujevac, 33126-3422

  • Clinical Centre Nis

    Niš, Nišavski Okrug, 18000

  • Clinical Center Vojvodina

    Novi Sad, Vojvodina, 21000

  • Clinical Hospital Centre Zemun

    Zemun, Belgrade, 11080

Other trials in Serbia

Bosnia and Herzegovina6 sites

  • Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology

    Banja Luka, Republika Srpska, 78000

  • The University Hospital Foca

    Foca, Republika Srpska, 73300

  • General Hospital Gradiska

    Gradiska, Republika Srpska, 78400

  • Clinical Center University of Sarajevo

    Sarajevo, Kanton Sarajevo, 71000

  • General Hospital Tesanj

    Tešanj, Zeničko-dobojski Kanton, 72460

  • General hospital Trebinje - Gastroenterology

    Trebinje, Republika Srpska, 89101

Other trials in Bosnia and Herzegovina

South Korea6 sites

  • Chungnam National University Hospital - Nephrology

    Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], 35015

  • National Health Insurance Service Ilsan Hospital - Nephrology

    Goyang-si, Gyeonggido [Kyonggi-do], 10444

  • Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6273

  • Samsung Medical Center - Nephrology

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591

  • Seoul National University Hospital - Nephrology

    Seoul, 03080

Other trials in South Korea

Malaysia5 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Seri Manjung

    Seri Manjung, Perak, 32400

Other trials in Malaysia

South Africa5 sites

  • Iatros International

    Bloemfontein, Free State, 9301

  • Tiervlei Trial Centre

    Cape Town, Western Cape, 7530

  • Office of Gulam Hoosain Vally

    Durban, KwaZulu-Natal, 4001

  • Dr J.M. Engelbrecht Trial Site

    Somerset West, Western Cape, 7130

  • Charlotte Maxeke Johannesburg Hospital

    Soweto, Gauteng, 2193

Other trials in South Africa

Taiwan5 sites

  • Taichung Veterans General Hospital - Nephrology

    Taichung, Taichung Municipality, 40705

  • China Medical University Hospital - Nephrology - Taichung

    Taichung, 406

  • National Taiwan University Hospital - Nephrology

    Taipei, Taipei Special Muncipality, 10002

  • Taipei Medical University - Shuang Ho Hospital - Nephrology

    Taipei, 110

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology

    Taoyuan, 33305

Other trials in Taiwan

Czechia4 sites

  • Nefrologie s.r.o.

    Prague, Praha 4, 149 00

  • IKEM

    Prague, 140 21

  • Alaron s.r.o.

    Prague, 160 00

  • Nemocnice Trebic, p.o.

    Třebíč, Třebíč, 674 01

Other trials in Czechia

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Renal Research

    Gosford, New South Wales, 2250

  • Austin Hospital

    Heidelberg, Victoria, 3084

Other trials in Australia

Croatia3 sites

  • University Hospital Center Split

    Split, 21000

  • Opca bolnica Vinkovci

    Vinkovci, Osjecko-baranjska Županija, 32100

  • University Hospital Centre Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Canada2 sites

  • Dr. Stephen S. Chow Medicine Professional Corporation

    Toronto, Ontario, M4C 5T2

  • Clinical Research Solutions Incorporated

    Waterloo, Ontario, N2T 0C1

Other trials in Canada

Hong Kong2 sites

  • Queen Mary Hospital - Medicine

    Hong Kong

  • Tung Wah Hospital

    Hong Kong

Other trials in Hong Kong

Israel2 sites

  • Nazareth Hospital EMMS

    Nazareth, Northern District, 16100

  • Rabin Medical Center

    Petah Tikwa, Central District, 49100

Other trials in Israel

Latvia2 sites

  • Dace Teterovska - Doctor's Practice

    Ogre, Ogre

  • P.Stradina Clinical University Hospital

    Riga

Other trials in Latvia

Lithuania1 site

  • Saules seimos medicinos centras

    Kaunas, Kaunas County, LT-49449

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

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.

Being tested
Placebo, KBP-5074
Keywords
Stage 3b/4 chronic kidney disease, Hypertension, Uncontrolled Hypertension, Blood pressure, Mineralocorticoid Receptor Antagonist, Randomized withdrawal
Medical subject headings
Renal Insufficiency, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • KBP-5074Drug

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

Study groups in NCT04968184
Study groupRoleWhat they receive
PlaceboPlacebo comparatorOpen-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.
Receives: Drug: Placebo
KBP-5074ExperimentalOpen-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.
Receives: Drug: KBP-5074

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Seated Trough Cuff Systolic Blood Pressure (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, was evaluated.

    Measured: From baseline to Week 12

  2. 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, was evaluated.

    Measured: From Week 48 to Week 52

Secondary outcomes (20)

  1. 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, were evaluated.

    Measured: From baseline to Week 24

  2. Changes in Seated Trough Cuff Diastolic Blood Pressure (DBP) From Baseline to Week 12

    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, was evaluated.

    Measured: From baseline to Week 12

  3. Changes in Urinary Albumin: Creatinine Ratio (UACR) From Baseline to Week 12 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, was evaluated.

    Measured: From baseline to Week 12

  4. 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, was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.

    Measured: From baseline to Week 12 and Week 24

  5. Changes in Seated Trough Cuff Diastolic Blood Pressure (DBP) From Baseline to Week 24

    Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP was evaluated.

    Measured: From baseline to Week 24

  6. Changes in Seated Trough Cuff DBP From Baseline to Week 48

    Effect of KBP-5074 on DBP by assessing change in seated trough cuff SBP was evaluated.

    Measured: From baseline to Week 48

  7. Changes in Seated Trough Cuff SBP From Baseline to Week 48

    Effect of KBP-5074 on SBP by assessing change in seated trough cuff SBP was evaluated.

    Measured: From baseline to Week 48

  8. Changes in UACR From Baseline to 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 was evaluated.

    Measured: From baseline to Week 24

  9. Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Macroalbuminuria

    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.

    Measured: From baseline to Week 12, Week 24, and Week 48

  10. Percentage Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Macroalbuminuria

    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.

    Measured: From baseline to Week 12, Week 24, and Week 48

  11. 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 was evaluated.

    Measured: From Week 48 to Week 52

  12. Change in UACR From Week 48 to Week 52 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 was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.

    Measured: Week 48 to Week 52

  13. Percentage Change in UACR From Week 48 to Week 52 in 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 was evaluated. Here, overall number of participants analyzed field represents the number of participants assessed for this particular outcome measure at indicated time frame.

    Measured: From Week 48 to Week 52

  14. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Until end of study (EOS) (Week 56) or Unscheduled visit or end of treatment or early termination (up to 32 months)

  15. Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Microalbuminuria

    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.

    Measured: From baseline to Week 12, Week 24, and Week 48

  16. Percentage Changes in UACR From Baseline to Week 12, Week 24, and Week 48 in Participants With Microalbuminuria

    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.

    Measured: From baseline to Week 12, Week 24, and Week 48

  17. Change in UACR From Week 48 to Week 52 in Participants With Microalbuminuria

    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.

    Measured: From Week 48 to Week 52

  18. Percentage Change in UACR From Week 48 to Week 52 in Participants With Microalbuminuria

    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.

    Measured: From Week 48 to Week 52

  19. Change in UACR From Week 48 to Week 52 in Participants With Macroalbuminuria

    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.

    Measured: From Week 48 to Week 52

  20. Percentage Change in UACR From Week 48 to Week 52 in Participants With Macroalbuminuria

    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.

    Measured: From Week 48 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start5 Nov 2021
  3. Primary completion30 Jan 2024
  4. Study completion10 Jul 2024

Why it stopped: Interim futility analysis showed primary endpoint not achieved

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968184
Sponsor's protocol ID
KBP5074-3-001
Other IDs
2021-003636-88
Acronym
Clarion-CKD
Status last verified
Aug 2026
First submitted
7 Jul 2021
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KBP-5074 in people with Chronic Kidney Diseases, run by Novo Nordisk A/S at 215 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in United States, China, Bulgaria, Georgia, Hungary and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Seated Trough Cuff Systolic Blood Pressure (SBP) From Baseline to Week 12 (time frame: From baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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