What side effects are associated with this type of intervention?

Common treatments for kidney failure include dialysis, kidney transplantation, and medications to manage symptoms and complications. Dialysis can cause side effects such as low blood pressure, muscle cramps, and infections. Kidney transplantation may lead to complications like rejection of the new kidney and infections due to immunosuppressive drugs. Medications used in kidney failure, such as diuretics and antihypertensives, can have side effects including electrolyte imbalances and hypotension. For treatments similar to LY3473329, which are often evaluated for pharmacokinetics and safety in renal impairment, side effects can include gastrointestinal issues, fatigue, and potential nephrotoxicity.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of kidney failure and related conditions. These include immunosuppressive agents like tacrolimus and sirolimus, which are used to prevent organ rejection in transplant patients. Additionally, drugs such as pembrolizumab and nivolumab have been approved for the treatment of advanced renal cell carcinoma. These treatments often undergo rigorous pharmacokinetic and safety evaluations to ensure their efficacy and tolerability in patients with varying degrees of renal function.

What other types of research exist?

Promising alternatives to LY3473329 for kidney failure patients include TC-5214, which has been studied for its pharmacokinetics in patients with impaired renal function, and TPN729MA, a novel PDE5 inhibitor with good preclinical pharmacokinetics and predicted human pharmacokinetics. Both drugs have shown potential in terms of absorption and stability, making them viable options for further consideration.

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LY3473329 for Kidney 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

Must not have

Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age

Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 34 days postdose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new medication called LY3473329 to see how it behaves in people with and without kidney problems. It measures how much of the drug gets into the bloodstream and how quickly it is removed from the body. The goal is to ensure the drug is safe and effective for everyone.

Who is the study for?

This trial is for adults with varying kidney function, from normal to impaired. Participants must have a BMI of 19-42 kg/m² and agree to use contraception if applicable. They should not have any conditions that could affect their safety, abnormal ECGs, high blood pressure or pulse rate risks, smoke heavily, recently donated a lot of blood, or consume excessive alcohol.

What is being tested?

The study tests LY3473329 in people with different levels of kidney health. It measures how much drug gets into the bloodstream and how quickly the body eliminates it. The trial also looks at the drug's safety and tolerability over up to an eight-week period including screening.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to LY3473329 which may include typical drug-related responses such as nausea, headaches, allergic reactions or other organ-specific issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I drink more than the recommended weekly alcohol limit.

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My hemoglobin is below 8 g/dL or I have symptoms of severe anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 34 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 34 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 34 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 last time point (AUC0-tlast) of LY3473329

PK: Maximum observed concentration (Cmax) of LY3473329

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: LY3473329 (Severe Renal Impairment)Experimental Treatment1 Intervention

LY3473329 administered orally to participants with severe renal impairment

Group II: LY3473329 (Moderate Renal Impairment)Experimental Treatment1 Intervention

LY3473329 administered orally to participants with moderate renal impairment

Group III: LY3473329 (Mild Renal Impairment)Experimental Treatment1 Intervention

LY3473329 administered orally to participants with mild renal impairment

Group IV: LY3473329 (End-Stage Renal Disease)Experimental Treatment1 Intervention

LY3473329 administered orally to participants with end-stage renal disease

Group V: LY3473329 (Control)Experimental Treatment1 Intervention

LY3473329 administered orally to participants with normal renal function

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3473329

2023

Completed Phase 2

~410

0 / 2Eligibility criteria met

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 include pharmacological agents, dialysis, and kidney transplantation. Pharmacological treatments, such as LY3473329, are often evaluated for their pharmacokinetics and safety in patients with renal impairment. These drugs work by either reducing the progression of kidney damage or managing symptoms and complications associated with kidney failure. For instance, some drugs may help control blood pressure, reduce proteinuria, or manage electrolyte imbalances. Understanding the mechanisms of these treatments is crucial for kidney failure patients because it helps in optimizing therapy, minimizing adverse effects, and improving overall outcomes.