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NCT04968184TerminatedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
666 (actual)
First submitted
7 Jul 2021
Start date
5 Nov 2021
Primary completion date
30 Jan 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT04968184
EudraCT number
2021-003636-88

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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).

Lab values

  • 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 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)

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (214)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Renal Research
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GosfordAustraliaUnknown status
Austin Hospital
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HeidelbergAustraliaUnknown status
Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology
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Banja LukaBosnia & HerzegovinaUnknown status
The University Hospital Foca
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FocaBosnia & HerzegovinaUnknown status
General Hospital Gradiska
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GradiskaBosnia & HerzegovinaUnknown status
Clinical center University of Sarajevo
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SarajevoBosnia & HerzegovinaUnknown status
General Hospital Tesanj
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TešanjBosnia & HerzegovinaUnknown status
General hospital Trebinje - Gastroenterology
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TrebinjeBosnia & HerzegovinaUnknown status
MHAT Dr. Tota Venkova
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GabrovoBulgariaUnknown status
Medical Center Hera EOOD
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MontanaBulgariaUnknown status
UMHAT Kaspela
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PlovdivBulgariaUnknown status
Medical Center Teodora,
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RousseBulgariaUnknown status
Comac Medical Ltd
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SofiaBulgariaUnknown status
UMHAT St. Ekaterina
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SofiaBulgariaUnknown status
5 th MHAT
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SofiaBulgariaUnknown status
DCC 22 - Sofia
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SofiaBulgariaUnknown status
Medical Center Excelsior
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SofiaBulgariaUnknown status
Medical Center Hera EOOD
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SofiaBulgariaUnknown status
Medical Center Synexus Sofia EOOD
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SofiaBulgariaUnknown status
University Hospital of Active Treatment Prof. Stoyan Kirkovich
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Stara ZagoraBulgariaUnknown status
MHAT 'Sv. Anna - Varna' AD
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VarnaBulgariaUnknown status
Dr. Stephen S. Chow Medicine Professional Corporation
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TorontoCanadaUnknown status
Clinical Research Solutions Incorporated
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WaterlooCanadaUnknown status
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
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BaotouChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Chao-Yang Hospital, Capital Medical University
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BeijingChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Beijing An Zhen Hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Sichuan Academy of Medical Sciences
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ChengduChinaUnknown status
The Southwest hospital of AMU
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ChongqingChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
The Third Affiliated Hospital,Sun Yat-Sen University
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GuangzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
Guangzhou First People's Hospital - Nephrology
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GuangzhouChinaUnknown status
The Affliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Zhejiang Hospital
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HangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
Shandong Provincial Hospital
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JinanChinaUnknown status
Jinhua Central Hospital
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JinhuaChinaUnknown status
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
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NanjingChinaUnknown status
The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology
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NanningChinaUnknown status
Shanghai General Hospital
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ShanghaiChinaUnknown status
Shanghai Sixth People's Hospital
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ShanghaiChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
The Central Hospital of Wuhan
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Zhongshan Hospital Xiamen University
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XiamenChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Yantai Yuhuangding Hospital(Base Cpmpus)
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YantaiChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University (East Compus)
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ZhengzhouChinaUnknown status
Alaron s.r.o.
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PragueCzechiaUnknown status
Nefrologie s.r.o.
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PragueCzechiaUnknown status
IKEM
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PragueCzechiaUnknown status
Nemocnice Trebic, p.o.
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TřebíčCzechiaUnknown status
Charité Universitätsmedizin Berlin
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BerlinGermanyUnknown status
Diabeteszentrum DO
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DortmundGermanyUnknown status
DaVita Clinical Research Germany GmbH
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DüsseldorfGermanyUnknown status
Medizinische Hochschule Hannover
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HanoverGermanyUnknown status
Universitätsklinikum Jena
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JenaGermanyUnknown status
Universitätsklinikum Mainz
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MainzGermanyUnknown status
Nephrologisches Zentrum Villingen-Schwenningen
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Villingen-SchwenningenGermanyUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Quirónsalud Barcelona
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BarcelonaSpainUnknown status
FUNDACION PUIGVERT - Nephrology Department
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Ribera Polusa
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LugoSpainUnknown status
Hospital público da Mariña
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LugoSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
LTD High Technology Hospital Medcenter
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BatumiGeorgiaUnknown status
JSC "Evex Hospitals'
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BatumiGeorgiaUnknown status
Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital
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GoriGeorgiaUnknown status
Ltd Marnecor
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MarneuliGeorgiaUnknown status
Bokhua Memorial Cardiovascular Centre
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TbilisiGeorgiaUnknown status
Emergency Cardiology Center named by acad. G. Chapidze
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TbilisiGeorgiaUnknown status
Ltd "Israel-Georgian Medical Research Clinic Helsicore"
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TbilisiGeorgiaUnknown status
Pineo Medical Ecosystem LtD
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TbilisiGeorgiaUnknown status
J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
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TbilisiGeorgiaUnknown status
JSC German Clinic
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TbilisiGeorgiaUnknown status
National Center of Urology Named after Laur Managadze
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TbilisiGeorgiaUnknown status
Aleksandre Aladashvili Clinic LLC
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TbilisiGeorgiaUnknown status
Tung Wah Hospital
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Hong KongHong KongUnknown status
Queen Mary Hospital - Medicine
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Hong KongHong KongUnknown status
University Hospital Center Split
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SplitCroatiaUnknown status
Opca bolnica Vinkovci
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VinkovciCroatiaUnknown status
University Hospital Centre Zagreb
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ZagrebCroatiaUnknown status
DRC Gyogyszervizsgalo Kozpont Kft
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BalatonfüredHungaryUnknown status
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
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BudapestHungaryUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
BKS Research
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HatvanHungaryUnknown status
Somogy Megyei Kaposi Mór Oktató Kórház
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KaposvárHungaryUnknown status
Kistarcsai Flor Ferenc Korhaz
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KistarcsaHungaryUnknown status
IPR Hungary Kft.
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MiskolcHungaryUnknown status
TaNa Med Kft.
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MosonmagyaróvárHungaryUnknown status
Coromed Smo Kft
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PécsHungaryUnknown status
Sonocor Egészségügyi Szolgáltató Kft.
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SzegedHungaryUnknown status
Nazareth Hospital EMMS
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NazarethIsraelUnknown status
Rabin Medical Center
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Petah TikwaIsraelUnknown status
Chungnam National University Hospital - Nephrology
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DaejeonSouth KoreaUnknown status
National Health Insurance Service Ilsan Hospital - Nephrology
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Goyang-siSouth KoreaUnknown status
Seoul National University Hospital - Nephrology
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center - Nephrology
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SeoulSouth KoreaUnknown status
Saules Seimos Medicinos Centras
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KaunasLithuaniaUnknown status
Dace Teterovska - Doctor's Practice
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OgreLatviaUnknown status
P. Stradina Clinical University Hospital
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RigaLatviaUnknown status
Hospital Raja Permaisuri Bainun
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IpohMalaysiaUnknown status
Hospital Raja Perempuan Zainab II
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Kota BharuMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
Hospital Seri Manjung
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Seri ManjungMalaysiaUnknown status
NZOZ Euromedica Sp. z o.o.
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GrudziądzPolandUnknown status
Synexus Polska Sp. z o.o.
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KatowicePolandUnknown status
Synexus Polska Sp. z o.o.
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LodzPolandUnknown status
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
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LodzPolandUnknown status
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
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LodzPolandUnknown status
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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LublinPolandUnknown status
Synexus Polska Sp z o o
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PoznanPolandUnknown status
Synexus Polska Sp. z o.o.
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WarsawPolandUnknown status
WroMedica I Bielicka A Strzalkowska s c
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WroclawPolandUnknown status
Zvezdara University Medical Center
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BelgradeSerbiaUnknown status
MSB General hospital - Clinical Research Center
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BelgradeSerbiaUnknown status
Military Medical Academy
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BelgradeSerbiaUnknown status
Clinical Center Kragujevac
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KragujevacSerbiaUnknown status
Clinical Centre Nis
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NišSerbiaUnknown status
Clinical Center Vojvodina
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Novi SadSerbiaUnknown status
Clinical Hospital Centre Zemun
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ZemunSerbiaUnknown status
China Medical University Hospital - Nephrology - Taichung
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital - Nephrology
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TaichungTaiwanUnknown status
Taipei Medical University - Shuang Ho Hospital - Nephrology
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TaipeiTaiwanUnknown status
National Taiwan University Hospital - Nephrology
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology
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TaoyuanTaiwanUnknown status
Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville
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AshevilleUnited StatesUnknown status
Fides Clinical Research
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AtlantaUnited StatesUnknown status
Southeastern Clinical Research Institute, LLC
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AugustaUnited StatesUnknown status
Gamma Clinical Research Institute
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AustinUnited StatesUnknown status
National Heart Institute
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Beverly HillsUnited StatesUnknown status
Davita Clinical Research-Hartford
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BloomfieldUnited StatesUnknown status
Massachusetts General Hospital (MGH) - Renal Associates Clinic
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BostonUnited StatesUnknown status
Synergy Healthcare
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BradentonUnited StatesUnknown status
Columbia Nephrology Associates, PA
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ColumbiaUnited StatesUnknown status
Columbus Associates LLC
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ColumbusUnited StatesUnknown status
Providence Health Partners-Center for Clinical Research
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DaytonUnited StatesUnknown status
Intermed Consultants
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EdinaUnited StatesUnknown status
DaVita Clinical Research- El Paso
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El PasoUnited StatesUnknown status
Kidney Consultants of El Paso, P.A.
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El PasoUnited StatesUnknown status
G & L Research LLC
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FoleyUnited StatesUnknown status
Amicis Research Center (Valencia)
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Granada HillsUnited StatesUnknown status
Amicis Research Center
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Granada HillsUnited StatesUnknown status
Physicians East, PA
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GreenvilleUnited StatesUnknown status
Clinical Investigation Specialists, Inc.
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GurneyUnited StatesUnknown status
Healthcare Research Network
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HazelwoodUnited StatesUnknown status
DaVita Clinical Research Houston
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HoustonUnited StatesUnknown status
Pioneer Research Solutions, Inc.
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HoustonUnited StatesUnknown status
Apogee Clinical Research, LLC
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HuntsvilleUnited StatesUnknown status
Eastern Nephrology Associates - Jacksonville
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JacksonvilleUnited StatesUnknown status
NYC Health + Hospitals / Queens - Diabetes Center of Excellence
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JamaicaUnited StatesUnknown status
Clinical Research Consultants
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Kansas CityUnited StatesUnknown status
Clinical Investigation Specialists
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KenoshaUnited StatesUnknown status
Knoxville Kidney Center PLLC
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KnoxvilleUnited StatesUnknown status
Amicis Research Center
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LancasterUnited StatesUnknown status
Healor Primary Care / CCT Research
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Las VegasUnited StatesUnknown status
DaVita Clinical Research (Nevada)
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Las VegasUnited StatesUnknown status
Central Georgia Kidney Specialists
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MaconUnited StatesUnknown status
Aventiv Research, Inc
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MesaUnited StatesUnknown status
Homestead Associates in Research Inc.
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MiamiUnited StatesUnknown status
Total Research Group
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MiamiUnited StatesUnknown status
Allied Biomedical Research Institute
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MiamiUnited StatesUnknown status
LCC Medical Research
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MiamiUnited StatesUnknown status
Oceane 7 Medical & Research Center, Inc.
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MiamiUnited StatesUnknown status
South Florida Research Phase I-IV, Inc
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MiamiUnited StatesUnknown status
Inpatient Research Clinic LLC
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Miami LakesUnited StatesUnknown status
San Marcus Research Clinic, Inc.
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Miami LakesUnited StatesUnknown status
New Generation Of Medical Research
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NaplesUnited StatesUnknown status
Eastern Nephrology Associates - New Bern
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New BernUnited StatesUnknown status
Davita Norfolk Square
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NorfolkUnited StatesUnknown status
Renal Consultants Medical Group - Granada Hills
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NorthridgeUnited StatesUnknown status
Sarkis Clinical
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OcalaUnited StatesUnknown status
Omega Research Orlando, LLC
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OrlandoUnited StatesUnknown status
North Carolina Nephrology, P.A
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RaleighUnited StatesUnknown status
Dominion Medical Associates, Inc.
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RichmondUnited StatesUnknown status
Mattoo & Bhat Medical Associates, PC
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RidgewoodUnited StatesUnknown status
Clinical Advancement Center, PLLC
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San AntonioUnited StatesUnknown status
Urology San Antonio - North Central
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San AntonioUnited StatesUnknown status
DaVita Clinical Research
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San AntonioUnited StatesUnknown status
United Clinical Research and Innovations
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South GateUnited StatesUnknown status
St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office
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St LouisUnited StatesUnknown status
Genesis Clinical Research
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TampaUnited StatesUnknown status
Santos Research Center, CORP
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TampaUnited StatesUnknown status
Albert Einstein's College of Medicine
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The BronxUnited StatesUnknown status
Kidney Medical Associates, PLLC
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The BronxUnited StatesUnknown status
Kidney Specialists of North Houston, PLLC
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The WoodlandsUnited StatesUnknown status
Solano Kidney Care
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VacavilleUnited StatesUnknown status
Kidney and Hypertension Center
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VictorvilleUnited StatesUnknown status
Desert Cities Dialysis - Amethyst
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VictorvilleUnited StatesUnknown status
Milwaukee Nephrologists, SC (Rich)
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WauwatosaUnited StatesUnknown status
Brookview Hills Research Associates, LLC
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Winston-SalemUnited StatesUnknown status
IATROS International
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BloemfonteinSouth AfricaUnknown status
Tiervlei Trial Centre
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Cape TownSouth AfricaUnknown status
Office of Gulam Hoosain Vally
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DurbanSouth AfricaUnknown status
Dr J.M. Engelbrecht Trial Site
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Somerset WestSouth AfricaUnknown status
Charlotte Maxeke Johannesburg Hospital
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SowetoSouth AfricaUnknown status

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