ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Официальное название

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Обзор

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.

Вмешательства

• Препарат ABBV-CLS-628
  IntraVenous Infusion
• Препарат Placebo
  IntraVenous Infusion

Первичные конечные точки

• Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [Срок оценки: Week 96]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 118 weeks]

Вторичные конечные точки (4)

• Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline [Срок оценки: Week 96]
• Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV) [Срок оценки: Week 48]
• Absolute Change in eGFR From Baseline [Срок оценки: Week 48]
• Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR [Срок оценки: Up to Week 96]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 39 центров

• University of Alabama at Birmingham — Birmingham
• Valiance Clinical Research - Huntington Park — Huntington Park
• Academic Medical Research Institute (AMRI) - Los Angeles — Los Angeles
• UC Irvine Medical Center — Orange
• National Institute of Clinical Research - Pomona — Pomona
• University Of California, San Francisco — San Francisco
• University of California Los Angeles Medical Center — Santa Monica
• Yale University School of Medicine — New Haven
• … и ещё 31 центр

Испания · 7 центров

Список центров уточняется — проверьте первичный протокол.

Португалия · 6 центров

• 2CA-Braga, Hospital de Braga — Braga
• Unidade Local de Saude do Algarve, EPE — Faro
• Hospital Curry Cabral — Lisbon
• Unidade Local de Saude de Lisboa Ocidental, EPE — Lisbon
• Unidade Local de Saude de Almada-Seixal, EPE — Almada
• Centro Hospitalar Do Funchal — Funchal

Франция · 5 центров

• Hopital Edouard Herriot — Lyon
• CHU Brest - Hôpital de la Cavale Blanche — Brest
• CHU Toulouse - Hôpital Rangueil — Toulouse
• Hopital de la Conception — Marseille
• Hopital Universitaire Necker Enfants Malades — Paris

Германия · 5 центров

• Universitaetsklinikum Heidelberg — Heidelberg
• TUM Klinikum rechts der Isar — Munich
• Medizinische Hochschule Hannover — Hanover
• Universitaetsklinikum Koeln — Cologne
• Charite Universitaetsmedizin Berlin - Campus Mitte — Berlin

South Korea · 5 центров

• Pusan National University Hospital — Busan
• Keimyung University Dongsan Hospital — Daegu
• … и ещё 3 центра

Австралия · 4 центра

• Westmead Hospital — Westmead
• Royal Brisbane and Women's Hospital — Brisbane
• Royal Adelaide Hospital — Adelaide
• Fiona Stanley Hospital — Murdoch

Канада · 4 центра

• Lakeridge Health Corporation-Oshawa — Oshawa
• Humber River Hospital — Toronto
• St. Michael's Hospital — Toronto
• Toronto General Hospital-University Health Network — Toronto

Италия · 4 центра

• A.O.U. Consorziale Policlinico di Bari — Bari
• AOU di Modena - Ospedale di Modena — Modena
• Azienda Ospedaliero-Universitaria Policlinico Umberto I — Rome
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica — Rome

Япония · 4 центра

• National Hospital Org Chiba Medical Center Chibahigashi National Hospital — Chiba
• Hokkaido University Hospital — Sapporo
• National Hospital Organization Kyoto Medical Center — Kyoto
• Juntendo University Hospital — Bunkyō-Ku

Нидерланды · 4 центра

• Universitair Medisch Centrum Groningen — Groningen
• Albert Schweitzer Ziekenhuis, locatie Dordwijk — Dordrecht
• LUMC — Leiden
• Erasmus Medisch Centrum — Rotterdam

Бельгия · 3 центра

• Cliniques Universitaires UCL Saint-Luc — Brussels
• CHU de Liege — Liège
• UZ Leuven — Leuven

Публикации

• Chen CY, Hadla M, Khambati I, Kashyap S, Westerfield V, Fedeles S, Besse W, Hopp K, Harris PC, Patel V, Chini E, Salih M, Barry MA, Chebib FT. Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease. Kidney360. 2026 Jul 1;7(7):1662-1676. doi: 10.34067/KID.0000001109. Epub 2025 Dec 12. PMID 41385299
• Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print. PMID 41348481

Идентификаторы

NCT: NCT06902558 · M25-147 · 2024-517143-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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