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Clinical Trial Details

Trial ID: L0150
Source ID: NCT06717698
Associated Drug: Nnc0519-0130
Title: A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: NNC0519-0130|DRUG: Placebo|DRUG: Semaglutide
Outcome Measures: Primary: Change in urinary albumin-to-creatinine ratio (UACR) at week 12, Measured as a ratio to baseline., From baseline (week 0) to end of a given maintenance dose period (week 12)|Change in urinary albumin-to-creatinine ratio (UACR) at week 24, Measured as a ratio to baseline., From baseline (week 0) to end of a given maintenance dose period (week 24)|Change in urinary albumin-to-creatinine ratio (UACR) at week 36, Measured as a ratio to baseline., From baseline (week 0) to end of a given maintenance dose period (week 36) | Secondary: Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021), Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2)., From baseline (week 0) to end of treatment (week 36)|Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021), Measured in mililitre per minute per 1.73 square metre (mL/min/1.73 m\^2)., From baseline (week 0) to end of treatment (week 36)|Relative change in body weight, Measured in percentage (%)., From baseline (week 0) to end of treatment (week 36)|Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 36)|Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 36)|Change in waist circumference, Measured in centimetres (cm)., From baseline (week 0) to end of treatment (week 36)|Change in glycated haemoglobin (HbA1c), Measured in percentage point (%-point)., From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)|Change in systolic blood pressure, Measured in millimetres of mercury (mmHg)., From baseline (week 0) to end of treatment (week 36)|Change in diastolic blood pressure, Measured in millimetres of mercury (mmHg)., From baseline (week 0) to end of treatment (week 36)|Number of treatment emergent adverse events (TEAEs), Measured as count of events., From baseline (week 0) to end of study (week 40)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 465
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-02
Completion Date: 2026-09-29
Results First Posted:
Last Update Posted: 2025-04-16
Locations: N America Res Inst - San Dimas, San Dimas, California, 91773, United States|NorCal Endocrinology and Internal Medicine, San Ramon, California, 94583, United States|Rocky Mount Reg VA Med-DN, Aurora, Colorado, 80045, United States|Northeast Research Institute, Fleming Island, Florida, 32003, United States|Encore Medical Research LLC, Hollywood, Florida, 33021, United States|Northeast Research Institute, Saint Augustine, Florida, 32080, United States|Clinical Research of Cent FL, Winter Haven, Florida, 33880, United States|Endeavor Health, Skokie, Illinois, 60077, United States|Velocity Clin. Res Valparaiso, Valparaiso, Indiana, 46383, United States|Elite Research Center, Flint, Michigan, 48532, United States|Albany Medical College, Albany, New York, 12203, United States|Carteret Medical Group, Morehead City, North Carolina, 28557, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Clinical Advancement Ctr, PLLC, San Antonio, Texas, 78212, United States|Tekton Research, San Antonio, Texas, 78251, United States|Providence Medical Research Center, Spokane, Washington, 99204, United States|Centro Médico CIMEL, Lanus Este, Buenos Aires, B1824KAJ, Argentina|Centro de Investigaciones Metabólicas, City of Buenos Aires, C1056ABI, Argentina|Instituto de Cardiología de Corrientes, Corrientes, W3400AMY, Argentina|Renalida, Mar Del Plata, Buenos Aires, B7600, Argentina|Instituto de Investigaciones Clinicas, Mar del Plata, B7600FZN, Argentina|Gosford Renal Research, Gosford, New South Wales, 2250, Australia|Heart of Australia, Chelmer, Queensland, 4068, Australia|Melbourne Renal Research Group, Reservoir, Victoria, 3073, Australia|Sunshine Hospital, St Albans, Victoria, 3021, Australia|Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV, Curitiba, Parana, 80045-110, Brazil|Instituto Pró-Renal Brasil, Curitiba, Parana, 80440-020, Brazil|Centro de Diabetes Curitiba, Curitiba, Parana, 80810-040, Brazil|Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande Do Sul, 90020-090, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos, Sao Paulo, 04038-002, Brazil|Specialized Rehabilitation Hospital Zdrave EAD, Bankya, 1320, Bulgaria|"Medical Centre Acad. Iv. Penchev" EOOD, Sofia, 1431, Bulgaria|"Medical Centre Acad. Iv. Penchev" EOOD, Sofia, 1431, Bulgaria|USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology, Sofia, 1431, Bulgaria|"UMHAT "Sveta Anna" Sofia", Sofia, 1750, Bulgaria|UMHAT Sofiamed, Sofia, 1750, Bulgaria|UMHAT Sveta Marina EAD, Varna, 9010, Bulgaria|MUDr. Petr Buček s.r.o., Frýdek Místek, 738 01, Czechia|CTC Hodonin s.r.o., Hodonin, 695 01, Czechia|FNKV-Internal Clinic-Nephrology, Praha 10, 100 34, Czechia|IKEM Klinika nefrologie, Praha 4, 140 21, Czechia|Fledip s.r.o., Praha 6, 160 00, Czechia|DiaVize s.r.o., Praha, 140 00, Czechia|Internist Care s.r.o., Smiřice, 503 03, Czechia|Nemocnice Český Krumlov, a.s., Český Krumlov, 381 01, Czechia|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|MS Ramaiah, Bengaluru, Karnataka, 560054, India|Government Medical College, Kozhikode, Kozhikode, Kerala, 673008, India|SMS Medical College & Hospital, Jaipur, Rajasthan, 302004, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|Diabetes Research Center, Hyderabad, Hyderabad, Telangana, 500082, India|Nizams Institute of Medical Science, Hyderabad, Telangana, 500082, India|Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia, L'Aquila, Abbruzzo, 67100, Italy|Università degli studi G. D'Annunzio Chieti Pescara - CAST, Chieti, Abruzzo, 66100, Italy|A.O.U. Bologna_ Policlinico S.Orsola Malpighi, Bologna, BO, 40138, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Azienda Ospedaliera Spedali Civili di Brescia, Brescia, 25121, Italy|Azienda Ospedaliera Luigi Sacco, Milano, 20157, Italy|Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello, Pisa, 56124, Italy|Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00168, Italy|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Fujisawa City Hospital_Kidney internal medicine, Kanagawa, 251-8550, Japan|Higashijujo Sakai Diabetes Clinic_Internal Medicine, Kita-ku, Tokyo, 114-0001, Japan|Koshigaya Municipal Hospital_Internal medicine, Saitama, 343-8577, Japan|Hanyu General Hospital_Internal Medicine, Saitama, 348-8505, Japan|Shinden Higashi Clinic, Sendai-shi, Miyagi, 983-0039, Japan|Omihachiman Community Medical Center_Nephrology, Siga, 523-0082, Japan|Kato Clinic of Internal Medicine, Tokyo, 125-0054, Japan|Pusan National University Hospital, Busan, 49241, Korea, Republic of|National Health Insurance Corporation Ilsan Hospital, Goyang, 410-719, Korea, Republic of|Hallym University Sacred Heart Hospital, Gyeonggi-Do, 14068, Korea, Republic of|Hanyang University GURI Hospital, Gyeonggi-do, 471-101, Korea, Republic of|Seoul Saint Mary's Hospital, Seoul, 06591, Korea, Republic of|Korea University Guro Hospital, Seoul, 08308, Korea, Republic of|Hospital Miri, Sarawak, Miri, 98000, Malaysia|Hospital Raja Permaisuri Bainun Ipoh, Ipoh, Perak, 30450, Malaysia|Hospital Sibu, Sibu, Sarawak, 96000, Malaysia|University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia|Hospital Universiti Sains Malaysia, Kota Bharu, Kelantan, 16150, Malaysia|Prince Court Medical Centre, Kuala Lumpur, 50450, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Hospital Pulau Pinang, Pulau Pinang, 10990, Malaysia|Hospital Sungai Buloh, Sungai Buloh, 47000, Malaysia|Kardio Life, Włocławek, Kujawsko-pomorskie, 87-800, Poland|Terpa Sp. z o.o. Sp. k., Lublin, Lubelskie Voivodeship, 20-333, Poland|Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie, Rzeszow, Podkarpackie, 35-301, Poland|Uniwersytecki Szpital Kliniczny w Bialymstoku, Białystok, 15-276, Poland|Uniwersyteckie Centrum Kliniczne SUM w Katowicach, Katowice, 40-752, Poland|Zanamed Medical Clinic Sp. z o.o., Lublin, 20-601, Poland|Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn, 10-561, Poland|Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie, Szczecin, 70-111, Poland|Szpitale Tczewskie S.A., Tczew, 83-110, Poland|PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warszawa, 02-507, Poland|Centrum Medyczne Oporow, Wroclaw, 52-416, Poland|SP ZOZ Centralny Szpital Kliniczny Uniwerystetu Medycznego w Łodzi, Łódź, 92-213, Poland|Nowy Szpital Sp. z o.o., Świecie, 86-100, Poland|Hospital Clinic i Provincial, Barcelona, 08036, Spain|Hospital Reina Sofia, Córdoba, 14004, Spain|Hospital Universitario de Getafe, Getafe, 28905, Spain|Hospital de Bellvitge, Hospitalet de Llobregat, 08907, Spain|Fundacion Jiménez Díaz, Madrid, 28040, Spain|Hospital Clinico San Carlos, Madrid, 28040, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Hospital Universitario Doctor Peset, Valencia, 46017, Spain|Erciyes Universitesi Tip Fakultesi, Kayseri, Melikgazi, 38039, Turkey|T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan, Adana, 01000, Turkey|Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali, Ankara, 06230, Turkey|Hacettepe Universitesi Tip Fakultesi Nefroloji Bilim Dali, Ankara, 06230, Turkey|Ankara Sehir Hastanesi Dahiliye Klinigi, Ankara, 06800, Turkey|Ankara Sehir Hastanesi Dahiliye Klinigi, Ankara, 06800, Turkey|Gaziantep Universitesi Tip Fakultesi Hastanesi, Gaziantep, 27070, Turkey|T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, 34722, Turkey|T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, 34722, Turkey|Ege Universitesi Tip Fakultesi Hastanesi, Izmir, 35100, Turkey|Kocaeli University Nephrology Department, Kocaeli, 41380, Turkey
URL: https://clinicaltrials.gov/show/NCT06717698

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress