Chronic Kidney Disease
Conditions
Interventions
DRUG: Volenrelaxin(Other Name: LY3540378)
Administered SC
DRUG: Placebo
Administered SC
[Study Arms]
Experimental: Volenrelaxin Dose 1
Participants will receive Volenrelaxin subcutaneously (SC)
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR) [Time Frame: Baseline, Week 12] | — |
Countries
Japan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed