Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

Chronic Kidney Diseases Clinical Trial

— Clarion-CKD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04968184
• Other study ID #: KBP5074-3-001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 5, 2021
• Est. completion date: January 15, 2025

Study information

• Verified date: February 2024
• Source: KBP Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 652
• Est. completion date: January 15, 2025
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Renal Research	Gosford	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Bosnia and Herzegovina	Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology	Banja Luka	Republika Srpska
Bosnia and Herzegovina	The University Hospital Foca	Foca	Republika Srpska
Bosnia and Herzegovina	General Hospital Gradiska	Gradiska	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo	Sarajevo	Kanton Sarajevo
Bosnia and Herzegovina	General Hospital Tesanj	Tešanj	Zenicko-dobojski Kanton
Bosnia and Herzegovina	General hospital Trebinje - Gastroenterology	Trebinje	Republika Srpska
Bulgaria	Mhat Dr.Tota Venkova	Gabrovo
Bulgaria	Medical Center Hera EOOD	Montana
Bulgaria	UMHAT Kaspela	Plovdiv
Bulgaria	Medical Center "Teodora"	Ruse
Bulgaria	5 th MHAT	Sofia	Sofia-Grad
Bulgaria	Comac Medical Ltd	Sofia	Sofia-Grad
Bulgaria	DCC 22 - Sofia	Sofia
Bulgaria	Medical Center ''Synexus Sofia'' EOOD	Sofia
Bulgaria	Medical Center Excelsior	Sofia	Sofia-Grad
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	UMHAT St. Ekaterina	Sofia	Sofia-Grad
Bulgaria	University Hospital of Active Treatment Prof. Stoyan Kirkovich	Stara Zagora
Bulgaria	MHAT"Sv.Anna-Varna"AD	Varna
Canada	Dr. Stephen S. Chow Medicine Professional Corporation	Toronto	Ontario
Canada	Clinical Research Solutions Incorporated	Waterloo	Ontario
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Nei Mongol (mn)
China	Beijing An Zhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Academy of Medical Sciences	Chengdu	Sichuan
China	The Southwest Hospital of AMU	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	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 Affliated Hospital of Guizhou Medical University	Guiyang	Guizhou
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	Shandong Provincial Hospital	Jinan	Shandong
China	Jinhua Central Hospital	Jinhua	Zhejiang
China	Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology	Nanning	Guangxi
China	Shanghai General Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Yantai Yuhuangding Hospital(Base Cpmpus)	Yantai	Shandong
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The First Affiliated Hospital of Zhengzhou University (East Compus)	Zhengzhou	Henan
Croatia	University Hospital Center Split	Split
Croatia	Opca bolnica Vinkovci	Vinkovci	Osjecko-baranjska Županija
Croatia	University Hospital Centre Zagreb	Zagreb	Grad Zagreb
Czechia	Nefrologie s.r.o.	Praha	Praha 4
Czechia	IKEM	Praha 4
Czechia	Alaron s.r.o.	Praha 6
Czechia	Nemocnice Trebic, p.o.	Trebic	Trebíc
Georgia	JSC "Evex Hospitals'	Batumi
Georgia	LTD "High technology hospital MEDCENTER"	Batumi	Ajaria
Georgia	Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital	Gori	Shida Kartli
Georgia	Ltd Marnecor	Marneuli	Kvemo Kartli
Georgia	"Pineo Medical Ecosystem"LTD	Tbilisi
Georgia	Aleksandre Aladashvili Clinic LLC	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	JSC German Clinic	Tbilisi
Georgia	LTD Israel-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	National Center of Urology Named after Laur Managadze	Tbilisi
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charité- Universitätsmedizin Berlin	Berlin
Germany	Diabeteszentrum DO	Dortmund	Nordrhein-Westfalen
Germany	DaVita Clinical Research Germany GmbH	Düsseldorf	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsklinikum Mainz	Mainz	Rheinland-Pfalz
Germany	Nephrologisches Zentrum Villingen-Schwenningen	Villingen-Schwenningen	Baden-Württemberg
Hong Kong	Queen Mary Hospital - Medicine	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Hungary	DRC Gyógyszervizsgáló Központ Kft.	Balatonfüred	Veszprém City
Hungary	Jahn Ferenc Dél-Pesti Kórház és Rendelointézet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	BKS Research	Hatvan	Heves
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Kistarcsai Flor Ferenc Korhaz	Kistarcsa Hungary	Pest
Hungary	IPR Hungary Kft.	Miskolc	Borsod-Abaúj-Zemplén
Hungary	TaNa Med Kft	Mosonmagyaróvár	Gyor-Moson-Sopron
Hungary	Coromed-Smo Kft.	Pécs	Baranya
Hungary	Sonocor Egészségügyi Szolgáltató Kft.	Szeged	Csongrád
Israel	Nazareth Hospital EMMS	Nazareth	HaZafon
Israel	Rabin Medical Center	Petah Tikwa	HaMerkaz
Korea, Republic of	Chungnam National University Hospital - Nephrology	Daejeon	Daejeon Gwang'yeogsi [Taejon-Kwangyokshi]
Korea, Republic of	National Health Insurance Service Ilsan Hospital - Nephrology	Goyang-si	Gyeonggido [Kyonggi-do]
Korea, Republic of	Seoul National University Hospital - Nephrology	Jongno-gu	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine	Seoul	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of	Samsung Medical Center - Nephrology	Seoul	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Latvia	Dace Teterovska - Doctor's Practice	Ogre	Ogres Novads
Latvia	P.Stradina Clinical University Hospital	Riga
Lithuania	Saules seimos medicinos centras	Kaunas	Kauno Apskritis
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu	Kelantan
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Hospital Seri Manjung	Seri Manjung	Perak
Poland	NZOZ Euromedica Sp. z o.o.	Grudziadz	Kujawsko-pomorskie
Poland	Synexus Polska Sp. z o.o.	Katowice
Poland	Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer	Lodz	Lódzkie
Poland	SP ZOZ Centralny Szpital Kliniczny UM w Lodzi	Lodz
Poland	Synexus Polska Sp. z. o.o.	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.	Warszawa
Poland	WroMedica I. Bielicka, A. Strzalkowska s.c.	Wroclaw
Serbia	Military Medical Academy	Belgrade
Serbia	MSB General hospital - Clinical Research Center	Belgrade
Serbia	Zvezdara University Medical Center	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Centre Nis	Niš	Nišavski Okrug
Serbia	Clinical Center Vojvodina	Novi Sad	Vojvodina
Serbia	Clinical Hospital Centre Zemun	Zemun	Belgrade
South Africa	Tiervlei Trial Centre	Bellville, Cape Town	Western Cape
South Africa	Iatros International	Bloemfontein	Free State
South Africa	Office of Gulam Hoosain Vally	Durban	Kwazulu-Natal
South Africa	Dr J.M. Engelbrecht Trial Site	Somerset West	Western Cape
South Africa	Charlotte Maxeke Johannesburg Hospital	Soweto	Gauteng
Spain	FUNDACION PUIGVERT - Nephrology Department	Barcelona
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Quironsalud Barcelona	Barcelona
Spain	Hospital público da Mariña	Burela	Lugo
Spain	Hospital Ribera Polusa	Burela	Lugo
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Consorcio Hospital General Universitario de Valencia	Valencia	Valenciana, Comunidad
Spain	Hospital Universitario Y Politécnico La Fe	Valencia
Taiwan	China Medical University Hospital - Nephrology - Taichung	Taichung
Taiwan	Taichung Veterans General Hospital - Nephrology	Taichung	Taichung Municipality
Taiwan	National Taiwan University Hospital - Nephrology	Taipei	Taipei Special Muncipality
Taiwan	Taipei Medical University - Shuang Ho Hospital - Nephrology	Taipei
Taiwan	Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology	Taoyuan
United States	Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville	Asheville	North Carolina
United States	Fides Clinical Research	Atlanta	Georgia
United States	Southeastern Clinical Research Institute, LLC	Augusta	Georgia
United States	Gamma Clinical Research Institute	Austin	Texas
United States	National Heart Institute	Beverly Hills	California
United States	Davita Clinical Research-Hartford	Bloomfield	Connecticut
United States	Massachusetts General Hospital (MGH) - Renal Associates Clinic	Boston	Massachusetts
United States	Synergy Healthcare	Bradenton	Florida
United States	Albert Einstein's College of Medicine	Bronx	New York
United States	Kidney Medical Associates, PLLC	Bronx	New York
United States	Columbia Nephrology Associates, PA	Columbia	South Carolina
United States	Columbus Associates LLC	Columbus	Georgia
United States	Providence Health Partners-Center for Clinical Research	Dayton	Ohio
United States	InterMed Consultants	Edina	Minnesota
United States	Davita Clinical Research El Paso	El Paso	Texas
United States	Kidney Consultants of El Paso, P.A.	El Paso	Texas
United States	G & L Research, LLC	Foley	Alabama
United States	Amicis Research Center	Granada Hills	California
United States	Amicis Research Center (Valencia)	Granada Hills	California
United States	Physicians East, PA	Greenville	North Carolina
United States	Clinical Investigation Specialists, Inc.	Gurney	Illinois
United States	Healthcare Research Network	Hazelwood	Missouri
United States	DaVita Clinical Research Houston	Houston	Texas
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Apogee Clinical Research, LLC	Huntsville	Alabama
United States	Eastern Nephrology Associates - Jacksonville	Jacksonville	North Carolina
United States	NYC Health + Hospitals / Queens - Diabetes Center of Excellence	Jamaica	New York
United States	Clinical Research Consultants	Kansas City	Missouri
United States	Clinical Investigation Specialists	Kenosha	Wisconsin
United States	Knoxville Kidney Center, PLLC	Knoxville	Tennessee
United States	Amicis Research Center	Lancaster	California
United States	DaVita Clinical Research (Nevada)	Las Vegas	Nevada
United States	Healor Primary Care /CCT Research	Las Vegas	Nevada
United States	Central Georgia Kidney Specialists	Macon	Georgia
United States	Aventiv Research, Inc	Mesa	Arizona
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Homestead Associates in Research, Inc	Miami	Florida
United States	LCC Medical Research	Miami	Florida
United States	Oceane 7 Medical&Research Center, Inc.	Miami	Florida
United States	South Florida Research Phase I-Iv, Inc.	Miami	Florida
United States	Total Research Group	Miami	Florida
United States	Inpatient Research Clinic, LLC	Miami Lakes	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	New Generation Of Medical Research	Naples	Florida
United States	Eastern Nephrology Associates - New Bern	New Bern	North Carolina
United States	Davita Norfolk Square	Norfolk	Virginia
United States	Renal Consultants Medical Group - Granada Hills	Northridge	California
United States	Sarkis Clinical	Ocala	Florida
United States	Omega Research Orlando, LLC	Orlando	Florida
United States	North Carolina Nephrology P.A.	Raleigh	North Carolina
United States	Dominion Medical Associates, Inc.	Richmond	Virginia
United States	Mattoo & Bhat Medical Associates, PC	Ridgewood	New York
United States	United Clinical Research and Innovations	S. Gate	California
United States	St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office	Saint Louis	Missouri
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	DaVita Clinical Research	San Antonio	Texas
United States	Urology San Antonio - North Central	San Antonio	Texas
United States	Genesis Clinical Research	Tampa	Florida
United States	Santos Research Center CORP	Tampa	Florida
United States	Kidney Specialists of North Houston, PLLC	The Woodlands	Texas
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	Milwaukee Nephrologists, SC (Rich)	Wauwatosa	Wisconsin
United States	Brookview Hills Research Associates, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
KBP Biosciences

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Georgia,  Germany,  Hong Kong,  Hungary,  Israel,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Poland,  Serbia,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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