GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

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

Status
RecruitingResults none
Why it is watched
non-weight indication: kidney
Who it enrolls
age 18 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Chronic Kidney Diseases
Interventions
Finerenone; Placebo Finerenone; Semaglutide; Placebo semaglutide
Conditions
Chronic Kidney Diseases
Phase and size
Phase 3 · 2000 participants
Dates
Start 2024-09-04
Primary completion 2029-12-31
Sponsor
The George Institute (Other)
Last checked
Oct 18, 2026
01Endpoints

What the trial will measure

  • Core Primary Outcome MeasureFrom randomisation to week 108
  • MRA Domain Primary Outcome MeasureFrom week 4 to week 108
  • GLP1-RA Domain Primary Outcome MeasureFrom week 0 to week 108
02Eligibility

Who can take part

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.
03Change log

Registry changes

No changes recorded since the trial was added.