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Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

NCT06598631

WithdrawnPhase 2

Sponsor: Eli Lilly and Company

Conditions: Chronic Kidney Disease

Interventions: Volenrelaxin, Placebo

Countries: United States, Australia, China, Japan, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

* 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.
Locations (35)
  • Downey, California, United States
  • Evergreen Park, Illinois, United States
  • Hinsdale, Illinois, United States
  • Huntley, Illinois, United States
  • Fort Wayne, Indiana, United States
  • Indianapolis, Indiana, United States
  • Metairie, Louisiana, United States
  • Flint, Michigan, United States
  • Greenville, North Carolina, United States
  • Jacksonville, North Carolina, United States
  • Kinston, North Carolina, United States
  • Morehead City, North Carolina, United States
  • New Bern, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Houston, Texas, United States
  • Odessa, Texas, United States
  • Gosford, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • Parkville, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Beijing, Beijing Municipality, China
  • Beijing, Beijing Municipality, China
  • Taian, Shandong, China
  • Yantai, Shandong, China
  • Ningbo, Zhejiang, China
  • Ningbo, Zhejiang, China
  • Kamakura-shi, Kanagawa, Japan
  • Niigata, Japan
  • Okayama, Japan
  • A Coruña, A Coruña [La Coruña], Spain
  • + 5 more on CT.gov