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Volenrelaxin for Chronic Kidney Disease
Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Have a diagnosis of Chronic Kidney Disease (CKD) based on eGFR category and albuminuria category per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Must not have
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
Have a documented New York Heart Association (NYHA) Class IV heart failure at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Summary
"This trial aims to see if Volenrelaxin is effective and safe for adults with Chronic Kidney Disease. The study will take around 12 weeks to complete."
Who is the study for?
This trial is for adults with Chronic Kidney Disease. Specific eligibility details are not provided, but typically participants should meet certain health criteria and may be excluded based on factors that could impact the study's results or their own safety.
What is being tested?
The trial is testing Volenrelaxin's effectiveness and safety over a 12-week period against a placebo to see if it can help adults with Chronic Kidney Disease.
What are the potential side effects?
While specific side effects of Volenrelaxin are not listed, they generally might include reactions at the injection site, potential allergic responses, or other symptoms related to its effect on kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been taking the highest dose I can tolerate of an ACE inhibitor or ARB for the last 90 days.
Select...
I have been diagnosed with Chronic Kidney Disease according to KDIGO criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of specific kidney diseases like polycystic kidney disease or lupus nephritis.
Select...
I have severe heart failure (NYHA Class IV).
Select...
I have hepatitis.
Select...
I need medicine regularly to suppress my immune system.
Select...
I have had an organ transplant or am waiting for one.
Select...
I was diagnosed with cancer within the last 5 years.
Select...
I experience symptoms of low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline in eGFR
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Volenrelaxin Dose 3Experimental Treatment1 Intervention
Participants will receive Volenrelaxin SC
Group II: Volenrelaxin Dose 2Experimental Treatment1 Intervention
Participants will receive Volenrelaxin SC
Group III: Volenrelaxin Dose 1Experimental Treatment1 Intervention
Participants will receive Volenrelaxin subcutaneously (SC)
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo SC
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,104 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,561 Total Patients Enrolled