What side effects are associated with this type of intervention?

Common treatments for kidney failure include medications like ACE inhibitors (e.g., enalapril), ARBs (e.g., valsartan), and diuretics, as well as dialysis and kidney transplantation. Known side effects of these treatments can include hyperkalemia, hypotension, dizziness, and increased risk of infections. Specific to medications, ACE inhibitors and ARBs can cause cough, elevated potassium levels, and kidney function deterioration in some cases. Diuretics may lead to electrolyte imbalances and dehydration. Dialysis can result in complications such as infections, low blood pressure, and muscle cramps. Kidney transplantation carries risks of rejection and infections due to immunosuppressive therapy.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for conditions that require careful consideration of renal function. Remifentanil, an opioid analgesic, has been studied for its altered pharmacokinetics in patients with end-stage renal failure. Tyrosine kinase inhibitors such as sorafenib and sunitinib, used in the treatment of metastatic renal cell carcinoma, have also been evaluated for their safety and efficacy in patients with renal impairment, including those on hemodialysis. These studies help inform dosing and safety guidelines for patients with compromised kidney function.

What other types of research exist?

Promising alternatives to LY3819469 for kidney failure patients include BIIB023, an anti-TWEAK monoclonal antibody, which has shown potential for treating lupus nephritis, and TC-5214, a nicotinic channel modulator, which has been studied for its pharmacokinetics in patients with impaired renal function. Both drugs have demonstrated target engagement and safety in clinical trials.

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Monoclonal Antibodies

LY3819469 for Renal Function

Phase 1

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 85 days postdose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new medication called LY3819469. It aims to see how much of the drug gets into the blood and how quickly it is removed in people with kidney problems compared to those without. The study will also check if the drug is safe and well-tolerated.

Who is the study for?

This trial is for adults with varying levels of kidney function, from normal to severe impairment or end-stage renal disease (ESRD) on stable hemodialysis. Participants must have a BMI between 19.0 and 42.0 kg/m² and use contraception if necessary. Those with significant health conditions, ECG abnormalities, low hemoglobin/anemia symptoms, allergies to LY3819469, or recent participation in similar trials are excluded.

What is being tested?

The study tests LY3819469's effects on individuals with different kidney functions by measuring how much drug enters the bloodstream and how quickly it's eliminated. The trial will also monitor safety and tolerability over up to 17 weeks including screening.

What are the potential side effects?

While specific side effects aren't listed here, the study aims to evaluate the general safety and tolerability of LY3819469 in participants which typically includes monitoring for any adverse reactions that may arise during the course.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 85 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 85 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 85 days postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469

PK: Maximum observed concentration (Cmax) of LY3819469

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: LY3819469 (Severe Renal Impairment)Experimental Treatment1 Intervention

LY3819469 administered SC to participants with severe renal impairment

Group II: LY3819469 (End-Stage Renal Disease)Experimental Treatment1 Intervention

LY3819469 administered SC to participants with end-stage renal disease (ESRD)

Group III: LY3819469 (Control)Experimental Treatment1 Intervention

LY3819469 administered subcutaneously (SC) to participants with normal renal function

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3819469

2023

Completed Phase 1

~120

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure, such as ACE inhibitors, ARBs, and immunosuppressants, work by reducing proteinuria and controlling blood pressure to slow the progression of kidney damage. The study of pharmacokinetics, like in the trial of LY3819469, is essential for understanding how these drugs are processed in patients with impaired renal function. This knowledge helps in adjusting dosages to ensure the medications are effective while minimizing the risk of toxicity, which is particularly important for maintaining the health and safety of kidney failure patients.

Optimal Mode of clearance in critically ill patients with Acute Kidney Injury (OMAKI)--a pilot randomized controlled trial of hemofiltration versus hemodialysis: a Canadian Critical Care Trials Group project.