Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

Phase 2

Terminated

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: Volenrelaxin

• 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

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Study Start: 2024-10-09
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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 \[2021\]

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, Andalucía, 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