Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

September 2, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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