Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

Inclusion Criteria:

• Have a diagnosis of Chronic Kidney Disease (CKD) based on eGFR category andalbuminuria category per the Kidney Disease: Improving Global Outcomes (KDIGO)criteria

• Have been on a maximally tolerated labeled daily dose of an angiotensin-convertingenzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for 90 dayspreceding screening and is expected to remain on a stable regimen through the study

• If on additional treatment for CKD, must be on stable dose for at least 90 daysbefore screening.

• If diagnosed with Type 2 Diabetes, should be on stable antihyperglycemic treatmentfor at least 90 days before screening.

Exclusion Criteria:

• Have any one of the following cardiovascular conditions 90 days prior to screening:

• myocardial infarction

• stroke

• hospitalization or urgent visit for heart failure, and

• coronary, carotid, or peripheral artery revascularization.

• Have a documented New York Heart Association (NYHA) Class IV heart failure at thetime of screening.

• Have chronic or intermittent hemodialysis or peritoneal dialysis 90 days prior toscreening.

• Have acute dialysis or acute kidney injury 90 days prior to screening.

• Have a history of a congenital or hereditary kidney disease, polycystic kidneydisease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA)-associatedvasculitis, and nephrotic syndrome

• Requires chronic immunosuppression.

• Have HbA1c >8.5% at screening

• Have had a transplanted organ or are awaiting an organ transplant

• Have a diagnosis or history of malignant disease within 5 years prior to baseline.

• Have symptomatic hypotension.

• Have acute or chronic hepatitis.