Study 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.
Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
3 other identifiers
interventional
N/A
5 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2024
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedOctober 2, 2025
October 1, 2025
3 months
September 12, 2024
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR)
Baseline, Week 12
Secondary Outcomes (2)
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Baseline, Week 12
Change from Baseline in eGFR
Baseline, Week 12
Study Arms (4)
Volenrelaxin Dose 1
EXPERIMENTALParticipants will receive Volenrelaxin subcutaneously (SC)
Volenrelaxin Dose 2
EXPERIMENTALParticipants will receive Volenrelaxin SC
Volenrelaxin Dose 3
EXPERIMENTALParticipants will receive Volenrelaxin SC
Placebo
PLACEBO COMPARATORParticipants will receive Placebo SC
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Rancho Research Institute
Downey, California, 90242, United States
Southwest Nephrology Associates
Evergreen Park, Illinois, 60805, 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 (NANI) - Fort Wayne
Fort Wayne, Indiana, 46804, United States
Nephrology Associates of Northern Illinois and Indiana - IKS - Indianapolis South
Indianapolis, Indiana, 46227, United States
Diabetes and Metabolism Associates, APMC
Metairie, Louisiana, 70006, United States
Elite Clinical Research Center
Flint, Michigan, 48532, United States
Eastern Nephrology Associates - Greenville
Greenville, North Carolina, 27834, United States
Eastern Nephrology Associates
Jacksonville, North Carolina, 28546, United States
Eastern Nephrology Associates- Kinston Office
Kinston, North Carolina, 28504, United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557, United States
Eastern Nephrology Associates- New Bern Office
New Bern, North Carolina, 28562, United States
Eastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401, United States
Endocrine Associates
Houston, Texas, 77004, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Renal Research - Gosford
Gosford, New South Wales, 2250, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Taian City Central Hospital
Taian, Shandong, 271000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Ningbo 2nd Hospital
Ningbo, Zhejiang, 315000, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010, China
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Ribera Polusa
Lugo, Lugo [Lugo], 27004, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 19, 2024
Study Start
October 9, 2024
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
October 2, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.