Chronic Kidney DiseasePhase 2NCT06598631
Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
A Phase 2 study testing Volenrelaxin in people with Chronic Kidney Disease, run by Eli Lilly and Company at 35 sites in 5 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Volenrelaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Oct 2024to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States16 sites
Rancho Research Institute
Downey, California, 90242
Southwest Nephrology Associates
Evergreen Park, Illinois, 60805
Elite Clinical Research Center
Flint, Michigan, 48532
Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne
Fort Wayne, Indiana, 46804
Eastern Nephrology Associates - Greenville
Greenville, North Carolina, 27834
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale
Hinsdale, Illinois, 60521
Endocrine Associates
Houston, Texas, 77004
Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley
Huntley, Illinois, 60142
Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
Indianapolis, Indiana, 46227
Eastern Nephrology Associates
Jacksonville, North Carolina, 28546
Eastern Nephrology Associates- Kinston Office
Kinston, North Carolina, 28504
Diabetes and Metabolism Associates, APMC
Metairie, Louisiana, 70006
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Eastern Nephrology Associates- New Bern Office
New Bern, North Carolina, 28562
Permian Research Foundation
Odessa, Texas, 79761
Eastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401
China6 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ningbo 2nd Hospital
Ningbo, Zhejiang, 315000
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010
Taian City Central Hospital
Taian, Shandong, 271000
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Spain6 sites
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Hospital Ribera Polusa
Lugo, Lugo [Lugo], 27004
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Australia4 sites
Renal Research - Gosford
Gosford, New South Wales, 2250
Liverpool Hospital
Liverpool, New South Wales, 2170
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Japan3 sites
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056
Niigata University Medical & Dental Hospital
Niigata, 951-8520
Okayama University Hospital
Okayama, 700-8558
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Volenrelaxin, Placebo
- Keywords
- eGFR, UACR
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolenrelaxinDrug
Also called LY3540378
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Volenrelaxin Dose 1 | Experimental | Participants will receive Volenrelaxin subcutaneously (SC) Receives: Drug: Volenrelaxin |
| Volenrelaxin Dose 2 | Experimental | Participants will receive Volenrelaxin SC Receives: Drug: Volenrelaxin |
| Volenrelaxin Dose 3 | Experimental | Participants will receive Volenrelaxin SC Receives: Drug: Volenrelaxin |
| Placebo | Placebo comparator | Participants will receive Placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
Measured: Baseline, Week 12
Secondary outcomes (2)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation [2009]
Measured: Baseline, Week 12
Change from Baseline in eGFR
Calculated using the CKD-EPI creatinine equation [2021]
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598631
- Sponsor's protocol ID
- 18839
- Other IDs
- J3E-MC-EZDC, 2024-513895-16-00
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06598631
- Acronym / sponsor ID
- 18839
- Conditions
- Chronic Kidney Disease
- Keywords
- eGFR, UACR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Volenrelaxin Dose 1 | Experimental | Drug: VolenrelaxinParticipants will receive Volenrelaxin subcutaneously (SC) |
| Volenrelaxin Dose 2 | Experimental | Drug: VolenrelaxinParticipants will receive Volenrelaxin SC |
| Volenrelaxin Dose 3 | Experimental | Drug: VolenrelaxinParticipants will receive Volenrelaxin SC |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- Have any one of the following cardiovascular conditions 90 days prior to screening:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolenrelaxinAlso: LY3540378Administered SC | Drug | Volenrelaxin Dose 1, Volenrelaxin Dose 2, Volenrelaxin Dose 3 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
Time frame: Baseline, Week 12
2 secondary outcomes
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 12
Change from Baseline in eGFR
Time frame: Baseline, Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Efficacy and Safety of Volenrelaxin in Adults with Chronic Kidney DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Volenrelaxin in people with Chronic Kidney Disease, run by Eli Lilly and Company at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, China, Spain, Australia, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.