. 2023 Jan 18;38(9):2041–2051. doi: 10.1093/ndt/gfad009

Table 1:

Inclusion and exclusion criteria for the FLOW trial.

Inclusion criteria	Exclusion criteria
• Informed consent • Male or female • Age ≥18 years (except for Japan where participants must be ≥20 years) • Diagnosis of T2D • HbA_1c ≤10% (≤86 mmol/mol) • Renal impairment, defined as either: eGFR^a ≥50 and ≤75 ml/min/1.73 m² and UACR >300 and <5000 mg/g^b,c or eGFR^a ≥25 and <50 ml/min/1.73 m² and UACR >100 and <5000 mg/g^b • Stable treatment with maximum labelled or tolerated dose of a RAAS blocking agent^d	• Known or suspected hypersensitivity to trial product(s) or related products • Pregnancy, breastfeeding or intention to become pregnant; child-bearing potential and not using a highly effective contraceptive method • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening • Any disorder which, in the investigator's opinion, might jeopardise a subject's safety or compliance with the protocol • Congenital or hereditary kidney diseases^e or autoimmune kidney diseases^f • MI, stroke, hospitalisation for unstable angina or TIA within 60 days prior to the day of screening; NYHA class IV; or planned coronary, carotid or peripheral artery revascularisation • Use of any GLP-1RA within 30 days prior to screening • Personal or first-degree relative(s) with a history of MEN2 or MTC • Chronic or intermittent haemodialysis or peritoneal dialysis within ≤90 days • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy^g • Presence or history of malignant neoplasm within 5 years prior to the day of screening^h • Prior solid organ transplant or awaiting solid organ transplant • Combination use of ACE inhibitor and ARB

Inclusion criteria

Exclusion criteria

• Informed consent
• Male or female
• Age ≥18 years (except for Japan where participants
must be ≥20 years)
• Diagnosis of T2D
• HbA_1c ≤10% (≤86 mmol/mol)
• Renal impairment, defined as either:
eGFR^a ≥50 and ≤75 ml/min/1.73 m² and UACR >300 and <5000 mg/g^b,c
or
eGFR^a ≥25 and <50 ml/min/1.73 m² and
UACR >100 and <5000 mg/g^b
• Stable treatment with maximum labelled or tolerated
dose of a RAAS blocking agent^d

• Known or suspected hypersensitivity to trial product(s) or related products
• Pregnancy, breastfeeding or intention to become pregnant; child-bearing potential and not
using a highly effective contraceptive method
• Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 30 days before screening
• Any disorder which, in the investigator's opinion, might jeopardise a subject's safety or
compliance with the protocol
• Congenital or hereditary kidney diseases^e or autoimmune kidney diseases^f
• MI, stroke, hospitalisation for unstable angina or TIA within 60 days prior to the day of
screening; NYHA class IV; or planned coronary, carotid or peripheral artery
revascularisation
• Use of any GLP-1RA within 30 days prior to screening
• Personal or first-degree relative(s) with a history of MEN2 or MTC
• Chronic or intermittent haemodialysis or peritoneal dialysis within ≤90 days
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy^g
• Presence or history of malignant neoplasm within 5 years prior to the day of screening^h
• Prior solid organ transplant or awaiting solid organ transplant
• Combination use of ACE inhibitor and ARB

^aBased on the CKD-EPI formula.

^bMeasurements taken ≤90 days before screening with subject in usual health condition.

^cNumber of participants with eGFR ≥60 ml/min/1.73 m² capped at 20% of randomised participants.

^dACE inhibitor or ARB, unless such treatment is contraindicated or not tolerated.

^eIncluding PKD.

^fIncluding glomerulonephritis or congenital urinary tract malformations.

^gVerified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation; eye examination performed by a suitably qualified healthcare provider (e.g. optometrist or ophthalmologist).

^hBasal and squamous cell skin cancer and any carcinoma in situ were allowed.

ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; MEN2, multiple endocrine neoplasia type 2; MI, myocardial infarction; MTC, medullary thyroid carcinoma; NYHA, New York Heart Association; PKD, polycystic kidney disease; TIA, transient ischaemic attack.