8 Participants Needed

Volenrelaxin for Chronic Kidney Disease

Recruiting at 35 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Must be taking: ACEi, ARB
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

You can continue your current medications if they are stable. You must stay on your ACE inhibitor or ARB and any other CKD or diabetes medications you are already taking.

What data supports the idea that Volenrelaxin for Chronic Kidney Disease is an effective drug?

The available research does not provide specific data on the effectiveness of Volenrelaxin for Chronic Kidney Disease. Instead, it highlights other treatments like renin-angiotensin system inhibitors, sodium-glucose cotransporter-2 inhibitors, and glucagon-like peptide-1 receptor agonists as effective options. These treatments have shown significant benefits in managing kidney disease, such as reducing the risk of kidney damage and slowing disease progression. Without specific data on Volenrelaxin, it's unclear how it compares to these established treatments.12345

What safety data exists for Volenrelaxin (LY3540378) in treating chronic kidney disease?

The provided research does not contain specific safety data for Volenrelaxin (LY3540378) in the treatment of chronic kidney disease. The articles focus on other treatments such as SGLT2 inhibitors, mineralocorticoid receptor antagonists like finerenone, and their safety profiles. Further research or clinical trial data specific to Volenrelaxin would be needed to answer this question.13678

Is the drug Volenrelaxin a promising treatment for Chronic Kidney Disease?

The information provided does not mention Volenrelaxin or its effects on Chronic Kidney Disease, so we cannot determine if it is a promising treatment based on the given research articles.2491011

What is the purpose of this trial?

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.

Research Team

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

I have been on a stable diabetes treatment for over 3 months.
I have been taking the highest dose I can tolerate of an ACE inhibitor or ARB for the last 90 days.
I have been diagnosed with Chronic Kidney Disease according to KDIGO criteria.
See 1 more

Exclusion Criteria

I have been on dialysis in the last 90 days.
Have HbA1c >8.5% at screening
I have had a heart attack, stroke, or other major heart issues in the last 3 months.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Volenrelaxin or placebo subcutaneously for the duration of the study

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Volenrelaxin
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as empagliflozin, canagliflozin, and dapagliflozin, have shown significant effectiveness in reducing risks associated with diabetic kidney disease (DKD), including albuminuria and progression to more severe kidney issues, based on recent clinical trials.
Finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), has been found to effectively reduce kidney-related complications in DKD patients without causing severe hyperkalemia, making it a safer alternative compared to traditional MRAs.
A Narrative Review of Diabetic Kidney Disease: Previous and Current Evidence-Based Therapeutic Approaches.Mima, A.[2022]
A new composite biomarker, developed using machine-learning techniques from a large observational study (PROVALID), can help identify which patients with diabetic kidney disease (DKD) will benefit from additional treatments alongside renin angiotensin system inhibitors (RASi).
The effectiveness of the additional treatment is measured by the annual percent change in estimated glomerular filtration rate (ΔeGFR), with higher increases indicating improved prognosis for patients receiving the combination therapy compared to those on RASi alone.
Candidate composite biomarker to inform drug treatments for diabetic kidney disease.Jones, RD., Abebe, S., Distefano, V., et al.[2023]
Sodium-glucose cotransporter-2 inhibitors (SGLT2i) have shown promise in managing chronic kidney disease (CKD) by addressing both kidney and heart health, representing a significant advancement in treatment options beyond traditional therapies.
The review also highlights the potential of novel non-steroidal mineralocorticoid receptor antagonists as a new strategy for improving cardiorenal health in patients with diabetic kidney disease, suggesting a shift in CKD management towards more comprehensive approaches.
The emerging pillars of chronic kidney disease: no longer a bystander in metabolic medicine.Wonnacott, A.[2023]

References

A Narrative Review of Diabetic Kidney Disease: Previous and Current Evidence-Based Therapeutic Approaches. [2022]
Candidate composite biomarker to inform drug treatments for diabetic kidney disease. [2023]
The emerging pillars of chronic kidney disease: no longer a bystander in metabolic medicine. [2023]
Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. [2021]
Management of type 2 diabetes in chronic kidney disease. [2021]
Finerenone: A Novel Third-Generation Mineralocorticoid Receptor Antagonist. [2023]
Mineralcorticoid receptor blockers in chronic kidney disease. [2022]
[Mineralcorticoid receptor blockers in chronic kidney disease]. [2022]
Dual blockade of the renin-angiotensin system in diabetic nephropathy: a randomized double-blind crossover study. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Aliskiren combined with losartan in type 2 diabetes and nephropathy. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effects of Vitamin D Receptor Activation and Dietary Sodium Restriction on Residual Albuminuria in CKD: The ViRTUE-CKD Trial. [2018]
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