AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllThe George Institute
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years 2. Known chronic kidney disease from any cause (eGFR โ‰ฅ25 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 โ‰ฅ5.0 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 โ‰ฅ23 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.
๐Ÿ’Š

What it tests

  • Finerenone
  • Placebo Finerenone
  • Semaglutide
  • Placebo semaglutide
๐Ÿ“

Where

51 sites
The Canberra Hospital
Garran, Australia
Nepean Blue Mountains Local Health District
Kingswood, Australia
St George Hospital
Kogarah, Australia
John Hunter Hospital
New Lambton Heights, Australia
Westmead Hospital
Westmead, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Australia
Townsville University Hospital
Douglas, Australia
West Moreton Hospital & Health Service
Ipswich, Australia

โ€ฆand 43 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy