Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease
- Registration Number
- NCT06598631
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive Placebo SC Volenrelaxin Dose 1 Volenrelaxin Participants will receive Volenrelaxin subcutaneously (SC) Volenrelaxin Dose 2 Volenrelaxin Participants will receive Volenrelaxin SC Volenrelaxin Dose 3 Volenrelaxin Participants will receive Volenrelaxin SC
- Primary Outcome Measures
Name Time Method Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) Baseline, Week 12 Calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation \[2009\]
Change from Baseline in eGFR Baseline, Week 12 Calculated using the CKD-EPI creatinine equation \[2021\]
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (35)
Renal Research - Gosford
🇦🇺Gosford, New South Wales, Australia
Taian City Central Hospital
🇨🇳Taian, Shandong, China
Endocrine Associates
🇺🇸Houston, Texas, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
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
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
Eastern Nephrology Associates- New Bern Office
🇺🇸New Bern, North Carolina, United States
Eastern Nephrology Associates - Wilmington
🇺🇸Wilmington, North Carolina, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, AndalucÃa, Spain
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Ningbo 2nd Hospital
🇨🇳Ningbo, Zhejiang, China
Okayama University Hospital
🇯🇵Okayama, Japan
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
The first affiliated hospital of Ningbo university
🇨🇳Ningbo, Zhejiang, China
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
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
Diabetes and Metabolism Associates, APMC
🇺🇸Metairie, Louisiana, United States
Elite Clinical Research Center
🇺🇸Flint, Michigan, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia