GLP-1 RA DSA Synopsis – Captivate Trial

Intervention(s)

The outcomes detailed in the Core Protocol apply to this DSA, with the following GLP-1 RA DSA-specific details:

Primary outcome: Chronic eGFR slope estimated from all available eGFR values from Week 0 to the end of treatment.

Potential participants must satisfy all the inclusion criteria in the Core Protocol, and also satisfy the following:

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.
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.
HbA1c ≤ 10% (≤ 86 mmol/L)
BMI ≥23 kg/m2 and <50 kg/m2
Treating physician believes semaglutide is clinically appropriate for the participant
Participant and treating physician are willing and able to perform GLP-1 RA DSA procedures
Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any GLP-1 RA DSA related procedures.

Potential participants must have none of the exclusion criteria in the Core Protocol, and must have none of the following:

Recipient of kidney transplant
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
Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Personal or first-degree relative(s) with a history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
Previous episode of pancreatitis
Uncontrolled thyroid disease, defined as TSH >6.0 mIU/L or <0.4 mIU/L
Type 1 diabetes
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 (i.e., 108 weeks if assigned to placebo)
Known allergy, intolerance, or contraindication to GLP-1 RAs
Currently pregnant or breast feeding, or intending to become pregnant or is of child-bearing potential, and not using a highly effective contraceptive method
Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.

Maximum sample size of approximately 1000 participants.