The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Обзор

CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

Подробное описание

Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life.

Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need.

CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.

Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.

Вмешательства

• Препарат Finerenone
  Finerenone 10mg or 20mg tablets, oral, once daily
• Препарат Placebo Finerenone
  Finerenone matched placebo tablets, oral, once daily

Первичные конечные точки

• eGFR slope [Срок оценки: From randomisation to week 108]

Вторичные конечные точки (6)

• Change in albuminuria [Срок оценки: From randomisation to week 24]
• Composite of 40% eGFR decline or kidney failure [Срок оценки: From randomisation to week 108]
• All-cause mortality at 108 weeks [Срок оценки: 108 weeks]
• Number of cardiovascular events [Срок оценки: 108 weeks]
• Safety and tolerability of treatment [Срок оценки: 108 weeks]
• Change in quality of life [Срок оценки: From randomisation to week 108]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
• Currently receiving standard of care treatment according to treating physician
• Eligible for randomisation in at least one recruiting domain-specific appendix
• Participant and treating physician are willing and able to perform trial procedures

Критерии исключения

• Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
• Life expectancy less than 6 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Индия · 16 центров

• Gitam Institute of Medical Sciences and Research — Visakhapatnam
• Patna Medical College and Hospital — Patna
• DKS Super Speciality Hospital, Raipur — Raipur
• Mysore Medical College — Dehradun
• GCS Medical College, Hospital & Research Centre — Ahmedabad
• Father Muller Medical College Hospital — Mangaluru
• Dr Moopen's Medical College — Meppādi
• CARE-CHL Hospital — Indore
• … и ещё 8 центров

Австралия · 13 центров

• The Canberra Hospital — Garran
• Nepean Blue Mountains Local Health District — Kingswood
• St George Hospital — Kogarah
• John Hunter Hospital — New Lambton Heights
• Westmead Hospital — Westmead
• Sunshine Coast Hospital and Health Service — Birtinya
• Townsville University Hospital — Douglas
• West Moreton Hospital & Health Service — Ipswich
• … и ещё 5 центров

Sri Lanka · 7 центров

• National Nephrology Specialized Hospital — Colombo
• National Hospital of Sri Lanka — Colombo
• Kandy National Hospital — Kandy
• Kurunegala Teaching Hospital — Kurunegala
• Sri Jayewardenepura General Hospital — Nugegoda
• Peradeniya Teaching Hospital — Peradeniya
• Colombo North Teaching Hospital — Ragama

Новая Зеландия · 6 центров

• Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital — Hastings
• Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital — Auckland
• Auckland City Hospital — Auckland
• Aotearoa Clinical Trials Trust, Middlemore Hospital — Auckland
• 201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand — Dunedin
• Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand — Whangarei

Испания · 1 центр

• Hospital Clinico Universitario València (INCLIVA) — Valencia

Публикации

• Kotwal SS, Perkovic V, Jardine MJ, Kim D, Shah NA, Lin E, Coggan S, Billot L, Vart P, Wheeler DC, de Boer IH, Zhang H, Hou FF, Sugawara Y, Marion J, Lewis RJ, Berry LR, McGlothlin A, Jha V, De Nicola L, Gorriz JL, Heerspink HJL; GKPTN and CAPTIVATE Investigators. The Global Kidney Patient Trials Network and the CAPTIVATE Platform Clinical Trial Design: A Trial Protocol. JAMA Netw Open. 2024 Dec 2; PMID 39661388
• Heerspink HJL, Kretzler M. Clinical Trials for Kidney Disease in the Era of Personalized Medicine. J Am Soc Nephrol. 2024 Aug 1;35(8):1123-1126. doi: 10.1681/ASN.0000000000000412. Epub 2024 May 9. No abstract available. PMID 39248631

Идентификаторы

NCT: NCT06058585 · P01351 · U1111-1324-3113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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