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 and albuminuria category per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
• Have been on a maximally tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for 90 days preceding 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 days before screening.
• If diagnosed with Type 2 Diabetes, should be on stable antihyperglycemic treatment for 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 the time of screening.
• Have chronic or intermittent hemodialysis or peritoneal dialysis 90 days prior to screening.
• Have acute dialysis or acute kidney injury 90 days prior to screening.
• Have a history of a congenital or hereditary kidney disease, polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, 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.