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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 15
Awards & highlights

Summary

This trial looks at how different levels of kidney function affect how a medicine is absorbed in the body.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
+3 more
Secondary outcome measures
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Clinically Significant Change in Laboratory Assessments
+3 more

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
~90

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
36 Previous Clinical Trials
5,652 Total Patients Enrolled
Erica KoenigStudy DirectorCerevel Therapeutics, LLC

Media Library

Emraclidine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05940402 — Phase 1
Kidney Failure Research Study Groups: Mild Renal Impairment, Moderate Renal Impairment, Severe Renal Impairment, Normal Renal Function
Kidney Failure Clinical Trial 2023: Emraclidine Highlights & Side Effects. Trial Name: NCT05940402 — Phase 1
Emraclidine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940402 — Phase 1
Kidney Failure Patient Testimony for trial: Trial Name: NCT05940402 — Phase 1
~18 spots leftby Jan 2025