Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,000 (estimated)
Sponsor
The George Institute · Other
Who this trial is looking for
This trial is looking for adults with chronic kidney disease (CKD) to find better treatments that can slow its progression. If you join, you will be part of a study that is comparing different treatments to see which ones work best.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have chronic kidney disease with an eGFR of 25 or higher
I am currently receiving standard treatment for my condition
I can take part in the trial procedures with my doctor
You may not be able to join if
I plan to start kidney replacement therapy or have a transplant within the next 6 months
My life expectancy is less than 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 treati…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.