RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: The George Institute • ClinicalTrials.gov ID: NCT06058585

Registry updated: 2026-10-05

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Description

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. CAPTIVATE includes multiple domains examining different therapies for CKD. Participants may enrol in one or more domains and domains will be added and closed over time. The platform operates under a core protocol with each domain described in a domain specific appendix.

Interventions

Finerenone (Drug)
Finerenone 10mg or 20mg tablets, oral, once daily
Placebo Finerenone (Drug)
Finerenone matched placebo tablets, oral, once daily
Semaglutide (Drug)
Semaglutide 1.0mg or 2.4mg pen injector, subcutaneous injection, once weekly
Placebo semaglutide (Drug)
Semaglutide matched pen injector, subcutaneous injection, once weekly

Eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures Exclusion Criteria: 1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 2. Life expectancy less than 6 months To be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above) MRA domain Inclusion Criteria: 1. Urine albumin-creatinine ratio (uACR) \>200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) \>300 mg/g (33.9 mg/mmol) at time of screening. 2. On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i\*, for 4 weeks before screening according to treating physician. 3. Treating physician believes finerenone is clinically appropriate for the participant. 4. Participant and treating physician are willing and able to perform MRA DSA procedures. 5. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any MRA DSA related procedures Exclusion Criteria: 1. Recipient of kidney transplant 2. Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening 3. Current treatment with MRA, where the treating physician or patient is not willing to discontinue this medication. If willing to discontinue the MRA, the potential participant must be re-screened after they have been on stable standard of care treatment for 4 weeks without the MRA. 4. Known allergy, intolerance or contraindication to MRAs 5. Current treatment with strong CYP3A4 inhibitors 6. Systolic BP \<110 mmHg or diastolic BP\<55 mmHg without antihypertensive therapy at time of screening 7. Severe hepatic impairment (defined as Child-Pugh Class C) 8. Adrenal insufficiency 9. Currently pregnant or breast feeding, or intending to become pregnant GLP-1 RA Domain Inclusion Criteria 1. Urine albumin-creatinine ratio (uACR) \>200 mg/g (22.6 mg/mmol) or urine proteincreatinine ratio (uPCR) \>300 mg/g (33.9 mg/mmol) at time of screening. 2. On a stable standard of care treatment for CKD, including a SGLT2i and maximum tolerated ACEi/ARB unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening. 3. HbA1c less than or equal to 10% (less than or equal to 86mmol/L) 4. BMI ≥23 kg/m2 and \< 50 kg/m2 5. Treating physician believes semaglutide is clinically appropriate for the participant 6. Participant and treating physician are willing and able to perform GLP-1 RA DSA procedures 7. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any GLP-1 RA DSA related procedures Exclusion Criteria 1. Recipient of kidney transplant 2. Major adverse cardiovascular events (MACE), consisting of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death, within 90 days prior to the day of screening 3. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure 4. Personal or first-degree relative(s) with a history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) 5. Previous episode of pancreatitis 6. Uncontrolled thyroid disease TSH\>6.0 mIU/L or \<0.4mlU/L 7. Type 1 diabetes 8. Current treatment with a GLP-1 RA, where it is in the participant's best interests to continue the GLP-1 RA or where the treating physician or patient is not willing to discontinue this medication for a minimum of 4 weeks prior to randomisation and for the full duration of the trial (ie. 108 weeks if assigned to placebo). 9. Known allergy, intolerance, or contraindication to GLP-1 RAs 10. Currently pregnant or breast feeding, or intending to become pregnant or is of child-bearing potential, and not using a highly effective contraceptive method 11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Conditions

Chronic Kidney Diseases

Locations

The Canberra Hospital — Garran, Australian Capital Territory, Australia
Nepean Blue Mountains Local Health District — Kingswood, New South Wales, Australia
St George Hospital — Kogarah, New South Wales, Australia
John Hunter Hospital — New Lambton Heights, New South Wales, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Sunshine Coast Hospital and Health Service — Birtinya, Queensland, Australia
Townsville University Hospital — Douglas, Queensland, Australia
West Moreton Hospital & Health Service — Ipswich, Queensland, Australia
Gold Coast Hospital and Health Service — Southport, Queensland, Australia
Royal Adelaide — Adelaide, South Australia, Australia
Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia
Austin Health — Heidelberg, Victoria, Australia
South Metropolitan Health Service, Fiona Stanley Hospital — Murdoch, Western Australia, Australia
Gitam Institute of Medical Sciences and Research — Visakhapatnam, Andhra Pradesh, India
Patna Medical College and Hospital — Patna, Bihar, India
DKS Super Speciality Hospital, Raipur — Raipur, Chhattisgarh, India
Mysore Medical College — Dehradun, Dehradun, India
GCS Medical College, Hospital & Research Centre — Ahmedabad, Gujarat, India
Aman Hospital & Research Center Vadodara — Vadodara, Gujarat, India
Father Muller Medical College Hospital — Mangaluru, Karnataka, India
Dr Moopen's Medical College — Meppādi, Kerala, India
CARE-CHL Hospital — Indore, Madhya Pradesh, India
Medway Hospital — Chennai, Tamil Nadu, India
Yashoda Hospital Hitec City — Hyderabad, Telangana, India
Apollo Hospitals — Hyderabad, Telangana, India
Charak Hospital and Research Centre — Lucknow, Uttar Pradesh, India
Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital — Dehradun, Uttarakhand, India
Fortis Hospital — Kolkata, West Bengal, India
North Bengal Medical College & Hospital — Siliguri, West Bengal, India
Max Superspeciality Hospital, Dehradun — Dehradun, India
Max Superspecialty Hospital, Ghaziabad — Ghaziabad, India
Aarupadai Veedu Medical College & Hospital (AVMCH), Puducherry — Puducherry, India
Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital — Hastings, Hawkes Bay, New Zealand
Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital — Auckland, New Zealand
Auckland City Hospital — Auckland, New Zealand
Aotearoa Clinical Trials Trust, Middlemore Hospital — Auckland, New Zealand
201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand — Dunedin, New Zealand
Midcentral - Palmerston North Hospital — Palmerston North, New Zealand
Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand — Whangarei, New Zealand
Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain
Vall d'Hebron University Hospital — Horta-Guinardó, Barcelona, Spain
Hospital Clinico Universitario València (INCLIVA) — Valencia, Espana, Spain
Jaffna Teaching Hospital — Jaffna, Northern Province, Sri Lanka
National Nephrology Specialized Hospital — Colombo, Polonnaruwa, Sri Lanka
University Hospital, Kotelawala Defence University — Dehiwala, Western Province, Sri Lanka
National Hospital of Sri Lanka — Colombo, Sri Lanka
Kandy National Hospital — Kandy, Sri Lanka
Kurunegala Teaching Hospital — Kurunegala, Sri Lanka
Sri Jayewardenepura General Hospital — Nugegoda, Sri Lanka
Peradeniya Teaching Hospital — Peradeniya, Sri Lanka
Colombo North Teaching Hospital — Ragama, Sri Lanka

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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