Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Volenrelaxin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06598631

2024-513895-16-00 (EU Trial (CTIS) Number)

J3E-MC-EZDC (Other Identifier)

18839

Details and patient eligibility

About

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 12 weeks.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 4 patient groups, including a placebo group

Volenrelaxin Dose 1

Experimental group

Description:

Participants will receive Volenrelaxin subcutaneously (SC)

Treatment:

Drug: Volenrelaxin

Volenrelaxin Dose 2

Experimental group

Description:

Participants will receive Volenrelaxin SC

Treatment:

Drug: Volenrelaxin

Volenrelaxin Dose 3

Experimental group

Description:

Participants will receive Volenrelaxin SC

Treatment:

Drug: Volenrelaxin

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo SC

Treatment:

Drug: Placebo