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Kidney drug trial pulled before it even started

NCT ID NCT06598631

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study was designed to test whether volenrelaxin could help adults with chronic kidney disease by reducing protein in the urine and preserving kidney function. It was a phase 2, placebo-controlled trial planned to last about 24 weeks. However, the study was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
volenrelaxin (also known as LY3540378)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Oct 2024

An estimate. Start dates often move.

Expected to finish

Dec 2024

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006, Spain

  • Diabetes and Metabolism Associates, APMC

    Metairie, Louisiana, 70006, United States

  • Eastern Nephrology Associates

    Jacksonville, North Carolina, 28546, United States

  • Eastern Nephrology Associates - Greenville

    Greenville, North Carolina, 27834, United States

  • Eastern Nephrology Associates - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Eastern Nephrology Associates- Kinston Office

    Kinston, North Carolina, 28504, United States

  • Eastern Nephrology Associates- New Bern Office

    New Bern, North Carolina, 28562, United States

  • Elite Clinical Research Center

    Flint, Michigan, 48532, United States

  • Endocrine Associates

    Houston, Texas, 77004, United States

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Hospital Ribera Polusa

    Lugo, Lugo [Lugo], 27004, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de, 28222, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010, Spain

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Lucas Research, Inc.

    Morehead City, North Carolina, 28557, United States

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne

    Fort Wayne, Indiana, 46804, United States

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale

    Hinsdale, Illinois, 60521, United States

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley

    Huntley, Illinois, 60142, United States

  • Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South

    Indianapolis, Indiana, 46227, United States

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520, Japan

  • Ningbo 2nd Hospital

    Ningbo, Zhejiang, 315000, China

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Permian Research Foundation

    Odessa, Texas, 79761, United States

  • Rancho Research Institute

    Downey, California, 90242, United States

  • Renal Research - Gosford

    Gosford, New South Wales, 2250, Australia

  • Southwest Nephrology Associates

    Evergreen Park, Illinois, 60805, United States

  • Taian City Central Hospital

    Taian, Shandong, 271000, China

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056, Japan

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099, China

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