Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
NCT ID: NCT06598631
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2024-10-09
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Volenrelaxin Dose 1
Participants will receive Volenrelaxin subcutaneously (SC)
Volenrelaxin
Administered SC
Volenrelaxin Dose 2
Participants will receive Volenrelaxin SC
Volenrelaxin
Administered SC
Volenrelaxin Dose 3
Participants will receive Volenrelaxin SC
Volenrelaxin
Administered SC
Placebo
Participants will receive Placebo SC
Placebo
Administered SC
Interventions
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Volenrelaxin
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Rancho Research Institute
Downey, California, United States
Southwest Nephrology Associates
Evergreen Park, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale
Hinsdale, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana (NANI) - Huntley
Huntley, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana (NANI) - Fort Wayne
Fort Wayne, Indiana, United States
Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
Indianapolis, Indiana, United States
Diabetes and Metabolism Associates, APMC
Metairie, Louisiana, United States
Elite Clinical Research Center
Flint, Michigan, United States
Eastern Nephrology Associates - Greenville
Greenville, North Carolina, United States
Eastern Nephrology Associates
Jacksonville, North Carolina, United States
Eastern Nephrology Associates- Kinston Office
Kinston, North Carolina, United States
Lucas Research, Inc.
Morehead City, North Carolina, United States
Eastern Nephrology Associates- New Bern Office
New Bern, North Carolina, United States
Eastern Nephrology Associates - Wilmington
Wilmington, North Carolina, United States
Endocrine Associates
Houston, Texas, United States
Permian Research Foundation
Odessa, Texas, United States
Renal Research - Gosford
Gosford, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Taian City Central Hospital
Taian, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Ningbo 2nd Hospital
Ningbo, Zhejiang, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, China
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Ribera Polusa
Lugo, Lugo [Lugo], Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Countries
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Related Links
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Efficacy and Safety of Volenrelaxin in Adults with Chronic Kidney Disease
Other Identifiers
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J3E-MC-EZDC
Identifier Type: OTHER
Identifier Source: secondary_id
2024-513895-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
18839
Identifier Type: -
Identifier Source: org_study_id
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