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NCT06717698RecruitingPhase 2

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
465 (estimated)
First submitted
30 Nov 2024
Start date
2 Dec 2024
Primary completion date
1 Sept 2026
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06717698
EU CT number
2024-510846-15-00
EudraCT number
2024-510846-15

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 465
  • From 2 Dec 2024 to the primary completion date, 1 Sept 2026
  • 133 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

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

Prior treatment

  • Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
  • Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to screening.
  • Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
  • Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
  • Only applicable for participants with type 2 diabetes (T2D): Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Other illness

  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency.

Who the study is looking for

  • Female of non-childbearing potential, or male.
    • For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.
    • HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimoles per mole (mmol/mol)\] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (\<)6.5 percentage (%) \[\<48 mmol/mol\] if not diagnosed with type 2 diabetes mellitus.
  • BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening.
  • Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less than (\<) 90 mL/min/1.73 m\^2.
  • Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (\<) 5000 milligram per gram (mg/g).
  • Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

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

Full criteria on ClinicalTrials.gov

Sites (133)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Investigaciones Metabólicas
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City of Buenos AiresArgentinaActive, not recruiting
Instituto de Cardiologia de Corrientes
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CorrientesArgentinaActive, not recruiting
Centro Médico CIMEL
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Lanús EsteArgentinaActive, not recruiting
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaActive, not recruiting
Renalida
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Mar del PlataArgentinaActive, not recruiting
Castle Hill Medical Centre
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Castle HillAustraliaActive, not recruiting
Heart of Australia
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ChelmerAustraliaActive, not recruiting
Gosford Renal Research
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GosfordAustraliaActive, not recruiting
Melbourne Renal Research Group
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ReservoirAustraliaNot yet recruiting
Sunshine Hospital - Western Centre for Health Research and Education
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St AlbansAustraliaActive, not recruiting
Specialized Hospital For Rehabilitation Health EAD
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BankyaBulgariaCompleted
Medical Center Zdrave-1 OOD
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KozloduyBulgariaCompleted
Dr. Nader Yabrudi Outpatient Clinic For Specialized Medical Assistance In Internal Diseases And Endocrinology Individual Practice EOOD
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SmolyanBulgariaCompleted
Medical Center Akad. Iv. Penchev EOOD
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SofiaBulgariaCompleted
University Hospital St. Anna
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SofiaBulgariaCompleted
University Multiprofile Hospital For Active Treatment Sofiamed OOD
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SofiyaBulgariaCompleted
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
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SofiyaBulgariaCompleted
MBAL Sveta Marina EAD
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VarnaBulgariaCompleted
Instituto Pro Renal Brasil
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CuritibaBrazilActive, not recruiting
Centro de Diabetes Curitiba
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CuritibaBrazilActive, not recruiting
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
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CuritibaBrazilActive, not recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilActive, not recruiting
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto AlegreBrazilActive, not recruiting
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
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São PauloBrazilActive, not recruiting
Nemocnice Český Krumlov, a.s.
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Český KrumlovCzechiaWithdrawn
MUDr. Petr Buček s.r.o.
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Frýdek-MístekCzechiaWithdrawn
CTC Hodonin s.r.o.
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HodonínCzechiaWithdrawn
IKEM Klinika nefrologie
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PragueCzechiaWithdrawn
FNKV-Internal Clinic-Nephrology
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PragueCzechiaWithdrawn
DiaVize s.r.o.
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PragueCzechiaWithdrawn
Fledip s.r.o.
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PragueCzechiaWithdrawn
Internist Care s.r.o
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SmiřiceCzechiaWithdrawn
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario de Getafe
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GetafeSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainCompleted
Hospital Universitario Doctor Peset
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ValenciaSpainCompleted
MS Ramaiah
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BengaluruIndiaNot yet recruiting
Endolife Specialty Hospitals
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GunturIndiaNot yet recruiting
Nizams Institute of Medical Science
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HyderabadIndiaNot yet recruiting
Diabetes Research Center, Hyderabad
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HyderabadIndiaNot yet recruiting
Diabetes, Thyroid and Endocrine Centre
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JaipurIndiaNot yet recruiting
SMS Medical College & Hospital
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JaipurIndiaNot yet recruiting
Government Medical College, Kozhikode
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KozhikodeIndiaNot yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyCompleted
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyCompleted
ASST Fatebenefratelli Sacco
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MilanItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
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AichiJapanActive, not recruiting
Naka Kinen Clinic_Internal medicine
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IbarakiJapanActive, not recruiting
Fujisawa City Hospital_Kidney internal medicine
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KanagawaJapanCompleted
Higashijujo Sakai Diabetes Clinic_Internal Medicine
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Kita-ku, TokyoJapanActive, not recruiting
Seino Internal Medicine Clinic_Internal medicine
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Koriyama-shi, FukushimaJapanActive, not recruiting
Koshigaya Municipal Hospital_Internal medicine
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SaitamaJapanActive, not recruiting
Hanyu General Hospital_Internal Medicine
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SaitamaJapanCompleted
Shinden Higashi Clinic
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Sendai-shi, MiyagiJapanRecruiting
Shinden Higashi Clinic_Internal medicine
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Sendai-shi, MiyagiJapanActive, not recruiting
Omihachiman Community Medical Center_Nephrology
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SigaJapanActive, not recruiting
Kato Clinic of Internal Medicine
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TokyoJapanRecruiting
Fukuwa Clinic
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TokyoJapanRecruiting
Kato Clinic of Internal Medicine_Internal Medicine
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TokyoJapanActive, not recruiting
Fukuwa Clinic_Internal Medicine
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TokyoJapanActive, not recruiting
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanActive, not recruiting
Pusan National University Hospital
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BusanSouth KoreaActive, not recruiting
National Health Insurance Corporation Ilsan Hospital
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Goyang-siSouth KoreaCompleted
Hallym UMC_Pyeongchon
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Gyeonggi-doSouth KoreaActive, not recruiting
Hanyang University Guri Hospital
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Gyeonggi-doSouth KoreaActive, not recruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaCompleted
Korea University Guro Hospital
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SeoulSouth KoreaActive, not recruiting
Hospital Pulau Pinang
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George TownMalaysiaActive, not recruiting
Hospital Raja Permaisuri Bainun Ipoh
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IpohMalaysiaActive, not recruiting
Hospital Universiti Sains Malaysia
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Kota Bharu, KelantanMalaysiaActive, not recruiting
Prince Court Medical Centre
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Kuala LumpurMalaysiaActive, not recruiting
University Malaya Medical Centre
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Kuala LumpurMalaysiaRecruiting
University Malaya Medical Centre
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Lembah PantaiMalaysiaActive, not recruiting
Hospital Melaka
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MalaccaMalaysiaActive, not recruiting
Hospital Miri
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MiriMalaysiaActive, not recruiting
Hospital Sibu
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SibuMalaysiaActive, not recruiting
Hospital Sungai Buloh
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Sungai BulohMalaysiaActive, not recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Uniwersyteckie Centrum Kliniczne im. Prof K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
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KatowicePolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Zanamed Medical Clinic Sp. z o.o.
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LublinPolandCompleted
Terpa Sp. z o.o. Sp. k.
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LublinPolandCompleted
Formed 2 Sp. z o.o.
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OswiecimPolandCompleted
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie
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RzeszówPolandCompleted
Nowy Szpital Sp. z o.o.
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SwieciePolandCompleted
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandCompleted
Szpitale Tczewskie S.A.
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TczewPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandCompleted
Kardio Life
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WłocławekPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandCompleted
Albany Medical College
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AlbanyUnited StatesActive, not recruiting
Rocky Mount Reg VA Med-DN
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AuroraUnited StatesCompleted
Davita Clinical Research
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El PasoUnited StatesActive, not recruiting
Northeast Research Institute
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Fleming IslandUnited StatesActive, not recruiting
Elite Research Center
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FlintUnited StatesCompleted
Encore Medical Research LLC
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HollywoodUnited StatesActive, not recruiting
Clinical Research Consultants
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Kansas CityUnited StatesActive, not recruiting
Carteret Medical Group
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Morehead CityUnited StatesActive, not recruiting
Northeast Research Institute
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Saint AugustineUnited StatesActive, not recruiting
Tekton Research
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San AntonioUnited StatesCompleted
Clinical Advancement Center
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San AntonioUnited StatesActive, not recruiting
N America Res Inst - San Dimas
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San DimasUnited StatesActive, not recruiting
NorCal Endocrinology and Internal Medicine
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San RamonUnited StatesActive, not recruiting
Endeavor Health
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SkokieUnited StatesCompleted
Providence Medical Research Center
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SpokaneUnited StatesActive, not recruiting
Velocity Clin. Res Valparaiso
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ValparaisoUnited StatesActive, not recruiting
Brookview Hills Research Associates, LLC
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Winston-SalemUnited StatesActive, not recruiting
Clinical Research of Cent FL
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Winter HavenUnited StatesCompleted
Adana Şehir Eğitim ve Araştırma Hastanesi
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AdanaTurkey (Türkiye)Active, not recruiting
Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali
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AnkaraTurkey (Türkiye)Recruiting
Hacettepe Üniversitesi Hastanesi- Nefroloji
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AnkaraTurkey (Türkiye)Completed
Ankara Bilkent Şehir Hastanesi-Dahiliye
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AnkaraTurkey (Türkiye)Active, not recruiting
Ankara Sehir Hastanesi Dahiliye Klinigi
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AnkaraTurkey (Türkiye)Recruiting
Gaziantep Universitesi Tip Fakultesi Hastanesi
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GaziantepTurkey (Türkiye)Recruiting
Gaziantep Üniversitesi Hastanesi- Endokrinoloji
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GaziantepTurkey (Türkiye)Active, not recruiting
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
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IstanbulTurkey (Türkiye)Active, not recruiting
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
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IstanbulTurkey (Türkiye)Recruiting
Ege Universitesi Hastanesi- Endokrinoloji
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IzmirTurkey (Türkiye)Active, not recruiting
Ege Universitesi Tip Fakultesi Hastanesi
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IzmirTurkey (Türkiye)Recruiting
Erciyes Üniversitesi Hastanesi - Nefroloji
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KayseriTurkey (Türkiye)Active, not recruiting
Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
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KocaeliTurkey (Türkiye)Active, not recruiting
Kocaeli University Nephrology Department
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KocaeliTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.