Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT06598631

Run by

Eli Lilly and Company

People needed

0

Starts

2024-10-09

Expected to finish

2024-12-30

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rancho Research Institute — Downey, California, United States
• Southwest Nephrology Associates — Evergreen Park, Illinois, United States
• Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale — Hinsdale, Illinois, United States
• Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley — Huntley, Illinois, United States
• Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne — Fort Wayne, Indiana, United States
• Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South — Indianapolis, Indiana, United States
• Diabetes and Metabolism Associates, APMC — Metairie, Louisiana, United States
• Elite Clinical Research Center — Flint, Michigan, United States
• Eastern Nephrology Associates - Greenville — Greenville, North Carolina, United States
• Eastern Nephrology Associates — Jacksonville, North Carolina, United States
• Eastern Nephrology Associates- Kinston Office — Kinston, North Carolina, United States
• Lucas Research, Inc. — Morehead City, North Carolina, United States
• Eastern Nephrology Associates- New Bern Office — New Bern, North Carolina, United States
• Eastern Nephrology Associates - Wilmington — Wilmington, North Carolina, United States
• Endocrine Associates — Houston, Texas, United States
• Permian Research Foundation — Odessa, Texas, United States
• Renal Research - Gosford — Gosford, New South Wales, Australia
• Liverpool Hospital — Liverpool, New South Wales, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Western Australia, Australia
• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Taian City Central Hospital — Taian, Shandong, China
• Yantai Yuhuangding Hospital — Yantai, Shandong, China
• Ningbo 2nd Hospital — Ningbo, Zhejiang, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.