Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

October 1, 2025 updated by: Eli Lilly and Company

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Renal Research - Gosford
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100029
        • Beijing AnZhen Hospital, Capital Medical University
    • Shandong
      • Taian, Shandong, China, 271000
        • Taian City Central Hospital
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University
      • Ningbo, Zhejiang, China, 315000
        • Ningbo 2nd Hospital
  • Japan
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Kanagawa
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Takai Internal Medicine Clinic
  • Spain
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Lugo [Lugo]
      • Lugo, Lugo [Lugo], Spain, 27004
        • Hospital Ribera Polusa
    • Madrid, Comunidad de
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clinico de Valencia
  • United States
    • California
      • Downey, California, United States, 90242
        • Rancho Research Institute
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Southwest Nephrology Associates
      • Hinsdale, Illinois, United States, 60521
        • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale
      • Huntley, Illinois, United States, 60142
        • Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne
      • Indianapolis, Indiana, United States, 46227
        • Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Diabetes and Metabolism Associates, APMC
    • Michigan
      • Flint, Michigan, United States, 48532
        • Elite Clinical Research Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Eastern Nephrology Associates - Greenville
      • Jacksonville, North Carolina, United States, 28546
        • Eastern Nephrology Associates
      • Kinston, North Carolina, United States, 28504
        • Eastern Nephrology Associates- Kinston Office
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc.
      • New Bern, North Carolina, United States, 28562
        • Eastern Nephrology Associates- New Bern Office
      • Wilmington, North Carolina, United States, 28401
        • Eastern Nephrology Associates - Wilmington
    • Texas
      • Houston, Texas, United States, 77004
        • Endocrine Associates
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volenrelaxin Dose 1
Participants will receive Volenrelaxin subcutaneously (SC)
Drug: Volenrelaxin
Administered SC
Other Names:
  • LY3540378
Experimental: Volenrelaxin Dose 2
Participants will receive Volenrelaxin SC
Drug: Volenrelaxin
Administered SC
Other Names:
  • LY3540378
Experimental: Volenrelaxin Dose 3
Participants will receive Volenrelaxin SC
Drug: Volenrelaxin
Administered SC
Other Names:
  • LY3540378
Placebo Comparator: Placebo
Participants will receive Placebo SC
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 12
Calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation [2009]
Baseline, Week 12
Change from Baseline in eGFR
Time Frame: Baseline, Week 12
Calculated using the CKD-EPI creatinine equation [2021]
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18839
  • J3E-MC-EZDC (Other Identifier: Eli Lilly and Company)
  • 2024-513895-16-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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