Table 1:
Inclusion and exclusion criteria in ZENITH-CKD.
| Inclusion criteria |
| Aged 18 years or older |
| Diagnosis of CKD, defined as: |
| eGFR ≥20 mL/min/1.73 m2 |
| UACR ≥150 and ≤5000 mg albumin/g creatinine based on a single first morning void spot urine sample at screening |
| No current or prior medical treatment with: |
| an SGLT2i, or any current fixed dose combination with SGLT2i (within 1 month of screening) |
| cytotoxic/immunosuppressive therapy or other immunotherapy (within 6 months of screening) |
| Body mass index ≤40 kg/m2 |
| Male or female of non-childbearing potential |
| Capable of giving signed informed consent |
| Exclusion criteria |
| Evidence of medical conditions including: |
| unstable, rapidly progressing renal disease or autosomal polycystic kidney disease |
| acute coronary syndrome events within 3 months prior to screening |
| unstable heart failure requiring hospitalization |
| BNP ≥200 pg/mL or NT-proBNP ≥600 pg/mL (BNP ≥400 pg/mL or NT-proBNP) |
| ≥1200 pg/mL, respectively, if associated with atrial fibrillation) measured by local laboratory at screening |
| heart failure owing to cardiomyopathies that would require other specific treatments |
| uncontrolled diabetes (HbA1c >12%) |
| type 1 diabetes |
| hyponatraemia, defined as serum Na+ <135 mmol/L at screening |
| prolonged QT interval (QTcF >470 ms) on ECG at screening or randomization |
| cardiac surgery planned or within 3 months prior to screening |
| heart transplantation |
| kidney transplantation |
| history of allergy/hypersensitivity to SGLT2is |
| stroke, transient ischaemic attack, carotid surgery or carotid angioplasty within 3 months prior to screening |
| active malignancy |
| severe hepatic impairment at screening |
| drug or alcohol abuse, current or within 12 months of screening |
| positive hepatitis C antibody, hepatitis B virus surface antigen or HIV test |
| confirmed COVID-19 infection by positive SARS-CoV-2 test at screening |
| Participation in another clinical study with an investigational product administered in the last 3 months |
| Involvement in the planning of the study |
| Plasma donation within 1 month of the clinic visit, or any blood donation/loss >500 mL during the 3 months prior to any visit at the clinic |
COVID-19: coronavirus disease 2019; ECG, electrocardiogram; HbA1c, glycated haemoglobin; HIV, human immunodeficiency virus; Na+, sodium; QT, QT interval; QTcF, QT interval corrected using Fridericia's formula; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.