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Набира участници Фаза 2 NCT06902558

A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Autosomal Dominant Polycystic Kidney Disease

Спонсор: AbbVie

Налично на: БГ
Обобщение
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria: * Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD. * Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening. Exclusion Criteria: * Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications. * Any exclusionary medical diseases, disorders, or conditions as described in the protocol.
Места на провеждане 11
Австралия (1)
Westmead Hospital /ID# 271156
Westmead , New South Wales
Белгия (1)
Cliniques Universitaires UCL Saint-Luc /ID# 270635
Brussels , Brussels Capital
Франция (1)
Hopital Edouard Herriot /ID# 271142
Lyon , Auvergne-Rhône-Alpes
Германия (1)
TUM Klinikum rechts der Isar /ID# 271522
Munich , Bavaria
Италия (1)
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563
Rome , Roma
Япония (1)
Hokkaido University Hospital /ID# 271385
Sapporo , Hokkaido
Нидерландия (1)
Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247
Dordrecht , South Holland
Португалия (1)
Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257
Almada , Setúbal District
Южна Корея (1)
Pusan National University Hospital /ID# 271429
Busan , Busan Gwang Yeogsi
Испания (1)
Hospital Universitari de Bellvitge /ID# 270489
L'Hospitalet de Llobregat , Barcelona
Site Coordinator
САЩ (1)
National Institute of Clinical Research - Garden Grove /ID# 271418
Garden Grove , California
Site Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
55 Years
Здрави доброволци
Не
Начална дата
09.06.2025
Крайна дата
01.08.2029
Регистрационен номер
NCT06902558
Източник
anzctr
Запитване за медицински туризъм

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