Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Megadott ok: Study was terminated due to a lack of foreseeable clinical benefit in the proposed chronic kidney disease population, following the termination of a related heart failure study that demonstrated no benefit in an overlapping patient group.
Key facts
- Where
- Downey, Evergreen Park, Flint, Fort Wayne, Greenville, Hinsdale, Houston, Huntley, Indianapolis, Jacksonville, Kinston, Metairie, Morehead City, New Bern, Odessa és Wilmington, Egyesült ÁllamokSee the 16 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Rancho Research InstituteDowney, Egyesült ÁllamokNo longer taking part
- Southwest Nephrology AssociatesEvergreen Park, Egyesült ÁllamokNo longer taking part
- Elite Clinical Research CenterFlint, Egyesült ÁllamokNo longer taking part
- Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort WayneFort Wayne, Egyesült ÁllamokNo longer taking part
- Eastern Nephrology Associates - GreenvilleGreenville, Egyesült ÁllamokNo longer taking part
- Nephrology Associates of Northern Illinois and Indiana (NANI) - HinsdaleHinsdale, Egyesült ÁllamokNo longer taking part
- Endocrine AssociatesHouston, Egyesült ÁllamokNo longer taking part
- Nephrology Associates of Northern Illinois and Indiana (NANI) - HuntleyHuntley, Egyesült ÁllamokNo longer taking part
- Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis SouthIndianapolis, Egyesült ÁllamokNo longer taking part
- Eastern Nephrology AssociatesJacksonville, Egyesült ÁllamokNo longer taking part
- Eastern Nephrology Associates- Kinston OfficeKinston, Egyesült ÁllamokNo longer taking part
- Diabetes and Metabolism Associates, APMCMetairie, Egyesült ÁllamokNo longer taking part
- Lucas Research, Inc.Morehead City, Egyesült ÁllamokNo longer taking part
- Eastern Nephrology Associates - New Bern OfficeNew Bern, Egyesült ÁllamokNo longer taking part
- Permian Research FoundationOdessa, Egyesült ÁllamokNo longer taking part
- Eastern Nephrology Associates | WilmingtonWilmington, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06598631EU 2024-513895-16-00
- Record updated
- 2026. szeptember 8.
- Original description
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.Read full original descriptionShow less
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
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.
Inclusion: 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: 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 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 had a transplanted organ or are awaiting an organ transplant; Have a documented New York Heart Association (NYHA) Class IV heart failure at the time of screening; Have a diagnosis or history of malignant disease within 5 years prior to baseline; Have acute or chronic hepatitis; 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; Have HbA1c >8.5% at screening; Requires chronic immunosuppression; Have symptomatic hypotension.