Chronic Kidney Disease
Conditions
Keywords
eGFR, UACR
Brief summary
The main purpose of this study is to investigate the efficacy and safety of Volenrelaxin in adults with Chronic Kidney Disease. The study will last about 24 weeks.
Interventions
DRUGVolenrelaxin
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR) | Baseline, Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline, Week 12 | Calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation \[2009\] |
| Change from Baseline in eGFR | Baseline, Week 12 | Calculated using the CKD-EPI creatinine equation \[2021\] |
Countries
Australia, China, Japan, Spain, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed