Clinical trial NCT04968184: Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Diseases
Keywords: Stage 3b/4 chronic kidney disease
Hypertension
Uncontrolled Hypertension
Blood pressure
Mineralocorticoid Receptor Antagonist
Randomized withdrawal
Lead sponsor: KBP Biosciences
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in seated trough cuff SBP from baseline to Week 12
timeFrame: From baseline to Week 12
measure: Change in seated trough cuff SBP from Week 48 to Week 52
timeFrame: Week 48 to Week 52
Secondary outcomes:
measure: Change in seated trough cuff SBP from baseline to Week 24
timeFrame: From baseline to Week 24
measure: Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24
timeFrame: From baseline to Week 12 and Week 24
measure: Changes in seated trough cuff SBP and DBP from baseline to Week 48
timeFrame: From baseline to Week 48
measure: Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
timeFrame: From baseline to Week 12 and Week 24
measure: Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
timeFrame: From baseline to Week 12 and Week 24
measure: Changes in UACR from baseline to Week 12, Week 24, and Week 48
timeFrame: From baseline to Week 12, Week 24, and Week 48
measure: Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48
timeFrame: From baseline to Week 12, Week 24, and Week 48
measure: Change in seated trough cuff DBP from Week 48 to Week 52
timeFrame: Week 48 to Week 52
measure: Change in UACR from Week 48 to Week 52
timeFrame: Week 48 to Week 52
measure: Percentage change in UACR from Week 48 to Week 52
timeFrame: Week 48 to Week 52
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Screening (Week -6 to -2) until EOS (Week 56) or Unscheduled visit or end of treatment or early termination
Other outcomes:
Locations:
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Apogee Clinical Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Aventiv Research, Inc
state: Arizona
city: Beverly Hills
country: United States
facility: National Heart Institute
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center (Valencia)
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: Lancaster
country: United States
facility: Amicis Research Center
state: California
city: Northridge
country: United States
facility: Renal Consultants Medical Group - Granada Hills
state: California
city: S. Gate
country: United States
facility: United Clinical Research and Innovations
state: California
city: Vacaville
country: United States
facility: Solano Kidney Care
state: California
city: Victorville
country: United States
facility: Desert Cities Dialysis - Amethyst
state: California
city: Victorville
country: United States
facility: Kidney and Hypertension Center
state: California
city: Bloomfield
country: United States
facility: Davita Clinical Research-Hartford
state: Connecticut
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Inpatient Research Clinic, LLC
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research, Inc
state: Florida
city: Miami
country: United States
facility: Total Research Group
state: Florida
city: Miami
country: United States
facility: LCC Medical Research
state: Florida
city: Miami
country: United States
facility: Oceane 7 Medical&Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: South Florida Research Phase I-Iv, Inc.
state: Florida
city: Naples
country: United States
facility: New Generation Of Medical Research
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Tampa
country: United States
facility: Santos Research Center CORP
state: Florida
city: Atlanta
country: United States
facility: Fides Clinical Research
state: Georgia
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Columbus
country: United States
facility: Columbus Associates LLC
state: Georgia
city: Macon
country: United States
facility: Central Georgia Kidney Specialists
state: Georgia
city: Gurney
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH) - Renal Associates Clinic
state: Massachusetts
city: Edina
country: United States
facility: InterMed Consultants
state: Minnesota
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Kansas City
country: United States
facility: Clinical Research Consultants
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office
state: Missouri
city: Las Vegas
country: United States
facility: Healor Primary Care /CCT Research
state: Nevada
city: Las Vegas
country: United States
facility: DaVita Clinical Research (Nevada)
state: Nevada
city: Bronx
country: United States
facility: Albert Einstein's College of Medicine
state: New York
city: Bronx
country: United States
facility: Kidney Medical Associates, PLLC
state: New York
city: Jamaica
country: United States
facility: NYC Health + Hospitals / Queens - Diabetes Center of Excellence
state: New York
city: Ridgewood
country: United States
facility: Mattoo & Bhat Medical Associates, PC
state: New York
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Jacksonville
country: United States
facility: Eastern Nephrology Associates - Jacksonville
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates - New Bern
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Nephrology P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Dayton
country: United States
facility: Providence Health Partners-Center for Clinical Research
state: Ohio
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center, PLLC
state: Tennessee
city: Austin
country: United States
facility: Gamma Clinical Research Institute
state: Texas
city: El Paso
country: United States
facility: Davita Clinical Research El Paso
state: Texas
city: El Paso
country: United States
facility: Kidney Consultants of El Paso, P.A.
state: Texas
city: Houston
country: United States
facility: DaVita Clinical Research Houston
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio - North Central
state: Texas
city: San Antonio
country: United States
facility: DaVita Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Kidney Specialists of North Houston, PLLC
state: Texas
city: Norfolk
country: United States
facility: Davita Norfolk Square
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates, Inc.
state: Virginia
city: Kenosha
country: United States
facility: Clinical Investigation Specialists
state: Wisconsin
city: Wauwatosa
country: United States
facility: Milwaukee Nephrologists, SC (Rich)
state: Wisconsin
city: Gosford
country: Australia
facility: Renal Research
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
state: Kanton Sarajevo
city: Banja Luka
country: Bosnia and Herzegovina
facility: Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology
state: Republika Srpska
city: Foca
country: Bosnia and Herzegovina
facility: The University Hospital Foca
state: Republika Srpska
city: Gradiska
country: Bosnia and Herzegovina
facility: General Hospital Gradiska
state: Republika Srpska
city: Trebinje
country: Bosnia and Herzegovina
facility: General hospital Trebinje - Gastroenterology
state: Republika Srpska
city: Tešanj
country: Bosnia and Herzegovina
facility: General Hospital Tesanj
state: Zeničko-dobojski Kanton
city: Sofia
country: Bulgaria
facility: 5 th MHAT
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: UMHAT St. Ekaterina
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Comac Medical Ltd
state: Sofia-Grad
city: Gabrovo
country: Bulgaria
facility: Mhat Dr.Tota Venkova
city: Montana
country: Bulgaria
facility: Medical Center Hera EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela
city: Ruse
country: Bulgaria
facility: Medical Center "Teodora"
city: Sofia
country: Bulgaria
facility: DCC 22 - Sofia
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center ''Synexus Sofia'' EOOD
city: Stara Zagora
country: Bulgaria
facility: University Hospital of Active Treatment Prof. Stoyan Kirkovich
city: Varna
country: Bulgaria
facility: MHAT"Sv.Anna-Varna"AD
city: Toronto
country: Canada
facility: Dr. Stephen S. Chow Medicine Professional Corporation
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Solutions Incorporated
state: Ontario
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing An Zhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital - Nephrology
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology
state: Guangxi
city: Guiyang
country: China
facility: The Affliated Hospital of Guizhou Medical University
state: Guizhou
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University (East Compus)
state: Henan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
state: Nei Mongol (mn)
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital(Base Cpmpus)
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Chongqing
country: China
facility: The Southwest Hospital of AMU
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
state: Grad Zagreb
city: Vinkovci
country: Croatia
facility: Opca bolnica Vinkovci
state: Osjecko-baranjska Županija
city: Split
country: Croatia
facility: University Hospital Center Split
city: Praha
country: Czechia
facility: Nefrologie s.r.o.
state: Praha 4
city: Trebic
country: Czechia
facility: Nemocnice Trebic, p.o.
state: Třebíč
city: Praha 4
country: Czechia
facility: IKEM
city: Praha 6
country: Czechia
facility: Alaron s.r.o.
city: Batumi
country: Georgia
facility: LTD "High technology hospital MEDCENTER"
state: Ajaria
city: Marneuli
country: Georgia
facility: Ltd Marnecor
state: Kvemo Kartli
city: Gori
country: Georgia
facility: Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital
state: Shida Kartli
city: Batumi
country: Georgia
facility: JSC "Evex Hospitals'
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: LTD Israel-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: "Pineo Medical Ecosystem"LTD
city: Tbilisi
country: Georgia
facility: JSC German Clinic
city: Tbilisi
country: Georgia
facility: National Center of Urology Named after Laur Managadze
city: Tbilisi
country: Georgia
facility: Bokhua Memorial Cardiovascular Centre
city: Tbilisi
country: Georgia
facility: Emergency Cardiology Center named by acad. G. Chapidze
city: Tbilisi
country: Georgia
facility: J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
city: Villingen-Schwenningen
country: Germany
facility: Nephrologisches Zentrum Villingen-Schwenningen
state: Baden-Württemberg
city: Dortmund
country: Germany
facility: Diabeteszentrum DO
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Germany GmbH
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital - Medicine
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Pécs
country: Hungary
facility: Coromed-Smo Kft.
state: Baranya
city: Miskolc
country: Hungary
facility: IPR Hungary Kft.
state: Borsod-Abaúj-Zemplén
city: Szeged
country: Hungary
facility: Sonocor Egészségügyi Szolgáltató Kft.
state: Csongrád
city: Mosonmagyaróvár
country: Hungary
facility: TaNa Med Kft
state: Gyor-Moson-Sopron
city: Hatvan
country: Hungary
facility: BKS Research
state: Heves
city: Kistarcsa Hungary
country: Hungary
facility: Kistarcsai Flor Ferenc Korhaz
state: Pest
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ Kft.
state: Veszprém City
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Petah Tikwa
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Nazareth
country: Israel
facility: Nazareth Hospital EMMS
state: HaZafon
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital - Nephrology
state: Daejeon Gwang'yeogsi [Taejon-Kwangyokshi]
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital - Nephrology
state: Gyeonggido [Kyonggi-do]
city: Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital - Nephrology
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - Nephrology
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Ogre
country: Latvia
facility: Dace Teterovska - Doctor's Practice
state: Ogres Novads
city: Riga
country: Latvia
facility: P.Stradina Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Saules seimos medicinos centras
state: Kauno Apskritis
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Seri Manjung
country: Malaysia
facility: Hospital Seri Manjung
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Grudziądz
country: Poland
facility: NZOZ Euromedica Sp. z o.o.
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
state: Lódzkie
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Lodz
country: Poland
facility: Synexus Polska Sp. z. o.o.
city: Lodz
country: Poland
facility: SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Wrocław
country: Poland
facility: WroMedica I. Bielicka, A. Strzalkowska s.c.
city: Zemun
country: Serbia
facility: Clinical Hospital Centre Zemun
state: Belgrade
city: Niš
country: Serbia
facility: Clinical Centre Nis
state: Nišavski Okrug
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center
city: Belgrade
country: Serbia
facility: MSB General hospital - Clinical Research Center
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Bloemfontein
country: South Africa
facility: Iatros International
state: Free State
city: Soweto
country: South Africa
facility: Charlotte Maxeke Johannesburg Hospital
state: Gauteng
city: Durban
country: South Africa
facility: Office of Gulam Hoosain Vally
state: Kwazulu-Natal
city: Bellville, Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Somerset West
country: South Africa
facility: Dr J.M. Engelbrecht Trial Site
state: Western Cape
city: Burela
country: Spain
facility: Hospital público da Mariña
state: Lugo
city: Burela
country: Spain
facility: Hospital Ribera Polusa
state: Lugo
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
state: Valenciana, Comunidad
city: Barcelona
country: Spain
facility: FUNDACION PUIGVERT - Nephrology Department
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Valencia
country: Spain
facility: Hospital Universitario Y Politécnico La Fe
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital - Nephrology
state: Taichung Municipality
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital - Nephrology
state: Taipei Special Muncipality
city: Taichung
country: Taiwan
facility: China Medical University Hospital - Nephrology - Taichung
city: Taipei
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital - Nephrology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology
Study officials:
References: