Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

JRCT ID: jRCT2051240155

Registered date:09/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease
• Date of first enrollment: 25/11/2024
• Target sample size: 280
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

DRUG: Volenrelaxin(Other Name: LY3540378)
Administered SC
DRUG: Placebo
Administered SC

[Study Arms]
Experimental: Volenrelaxin Dose 1
Participants will receive Volenrelaxin subcutaneously (SC)
Interventions:
Drug: Volenrelaxin
Experimental: Volenrelaxin Dose 2
Participants will receive Volenrelaxin SC
Interventions:
Drug: Volenrelaxin
Experimental: Volenrelaxin Dose 3
Participants will receive Volenrelaxin SC
Interventions:
Drug: Volenrelaxin
Placebo Comparator: Placebo
Participants will receive Placebo SC
Interventions:
Drug: Placebo

Outcome(s)

• Primary Outcome: Percent Change from Baseline of Urine Albumin-Creatinine Ratio (UACR) [Time Frame: Baseline, Week 12]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06598631