What is the mechanism of action of this treatment?

Common treatments for kidney failure include ACE inhibitors and ARBs, which work by reducing blood pressure and proteinuria, thereby slowing the progression of kidney disease. Immunosuppressive therapies, such as cyclophosphamide and prednisone, are used to manage autoimmune conditions affecting the kidneys by reducing inflammation and immune response. Plasmapheresis is another treatment that removes harmful antibodies from the blood, particularly useful in conditions like anti-GBM disease. Understanding these mechanisms is crucial for kidney failure patients as they directly influence the effectiveness of treatment and management of the disease, potentially improving outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for kidney failure, particularly those involving pharmacokinetics in renal impairment, can have a range of side effects. For example, drugs like lenalidomide and carfilzomib, used in multiple myeloma, can cause acute kidney injury, hypertension, and fatigue. Other treatments, such as intravenous immune globulin (IVIG), may lead to fluid retention, headache, and in severe cases, acute renal failure. Additionally, PCSK9 inhibitors, although not primarily used for kidney failure, are considered safe for patients with renal impairment but can cause mild side effects like injection site reactions and flu-like symptoms. It is crucial to monitor kidney function and adjust dosages accordingly to minimize these adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for kidney failure often include immunosuppressive drugs such as mycophenolate mofetil, azathioprine, and cyclophosphamide, which are used to manage conditions like anti-GBM disease and IgA nephropathy. Additionally, drugs like ezetimibe have been shown to ameliorate the decline of renal function post-transplant. While Emraclidine's specific approval status and related drugs are not detailed, the focus on pharmacokinetics in renal impairment suggests a broader interest in optimizing drug dosing and safety in patients with compromised kidney function.

What other types of research exist?

Promising alternatives to Emraclidine for kidney failure patients include: 1) Cyclosporine, which has shown significant improvement in creatinine clearance and proteinuria in patients with membranous nephropathy. 2) Sirolimus-based therapy, which has been effective in reducing the rate of renal function decline in kidney transplant recipients. 3) Ezetimibe, which has demonstrated safety and effectiveness in ameliorating the decline of renal function in hypercholesterolemic kidney transplant patients. 4) Rolofylline, an adenosine A1 receptor antagonist, which has shown potential in preserving renal function in patients with acute heart failure and renal impairment.

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Emraclidine for Renal Impairment

Phase 1

Recruiting

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild, moderate, or severe renal impairment based on eGFR determined using the 2021 CKD-EPI equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value

Body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs])

Must not have

Participants who require dialysis

Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called emraclidine to see how it behaves in people with different levels of kidney function. The study includes participants with mild, moderate, and severe kidney problems and compares them to those with normal kidney function. Researchers want to understand if kidney issues change how the body processes this drug.

Who is the study for?

This trial is for adults with varying degrees of kidney function, from normal to severe impairment. Participants must have a BMI between 18.0 and 42.0 kg/m^2 and weigh at least 50 kg. Women who can bear children should use birth control during the study and for a week after the last dose. People with recent COVID-19, substance abuse issues, or significant health problems other than kidney disease are excluded.

What is being tested?

The trial is testing Emraclidine's effects in people with different levels of kidney health by giving them one oral dose and seeing how their bodies process it compared to those with normal kidneys.

What are the potential side effects?

Potential side effects aren't specified here but generally could include reactions where the drug was given, changes in blood tests or vital signs, or any unusual symptoms that might be related to taking Emraclidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, based on a specific test, shows I have some level of kidney disease.

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My BMI is between 18 and 42, and I weigh at least 50 kg (110 lbs).

Exclusion Criteria

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

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I require dialysis.

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I have received an organ transplant or am waiting for one.

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I do not plan to get a COVID-19 vaccine or booster during the trial or within 7 days after the last dose of the trial medication.

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I have been diagnosed with nephrotic syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 5 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Severe Renal ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Group II: Normal Renal FunctionExperimental Treatment1 Intervention

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Group III: Moderate Renal ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Group IV: Mild Renal ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emraclidine

2024

Completed Phase 1

~110

0 / 6Eligibility 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 ACE inhibitors and ARBs, which work by reducing blood pressure and proteinuria, thereby slowing the progression of kidney disease. Immunosuppressive therapies, such as cyclophosphamide and prednisone, are used to manage autoimmune conditions affecting the kidneys by reducing inflammation and immune response. Plasmapheresis is another treatment that removes harmful antibodies from the blood, particularly useful in conditions like anti-GBM disease. Understanding these mechanisms is crucial for kidney failure patients as they directly influence the effectiveness of treatment and management of the disease, potentially improving outcomes and quality of life.

Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study.