Emraclidine for Renal Impairment

No longer recruiting at 3 trial locations

Overseen By Cerevel Clinical Trial Support

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Suicidal ideation, Substance use disorder, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a drug called emraclidine (an experimental treatment) behaves in people with varying levels of kidney function. Participants will receive a single dose of the medication, and researchers will compare its processing in those with mild, moderate, and severe kidney issues to those with normal kidney function. This trial suits individuals with stable kidney conditions who do not require dialysis. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify if you need to stop your current medications. However, participants with renal impairment should have stable concomitant medications for managing their medical history. It's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that emraclidine is likely to be safe for humans?

Research shows no specific safety information for emraclidine in individuals with kidney problems. This study remains in the early stages, as researchers work to determine the drug's safety and tolerability. The primary goal of these early trials is to observe the body's reaction to the drug and identify any side effects. Because this is an initial study phase, detailed safety information is not yet available. Participants will receive a single dose, allowing researchers to gather early safety data without long-term exposure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for renal impairment focus on managing symptoms or slowing progression, often involving medications like ACE inhibitors or angiotensin receptor blockers. But emraclidine works differently, targeting the condition with a novel approach. Researchers are excited about emraclidine because it offers a unique mechanism of action that may directly improve kidney function rather than just managing symptoms. This could mean more effective treatment options for patients with varying degrees of renal impairment. Additionally, its administration as a single oral dose could improve convenience and adherence compared to more complex treatment regimens.

What evidence suggests that emraclidine might be an effective treatment for renal impairment?

Research has shown that emraclidine affects certain brain areas that control mood and thinking, potentially aiding mental health issues like schizophrenia. Early findings suggest that emraclidine might improve symptoms such as hallucinations and delusions. Although more research is needed, these early results are promising and suggest that emraclidine could be an effective treatment. In this trial, participants with varying levels of renal function—mild, moderate, severe impairment, and normal function—will receive a single oral dose of emraclidine to assess how kidney function influences the drug's effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Stable concomitant medications for the management of individual participant's medical history; on a case-by-case basis, with input from the sponsor, participants receiving fluctuating concomitant medication/treatment may be considered if the underlying disease is under control

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

My kidney function is normal, with an eGFR of 90 mL/min or more.

Exclusion Criteria

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

If you have had thoughts about wanting to die or have made plans to harm yourself, or if your doctor thinks you are at serious risk of suicide, you cannot participate in the trial. If you had these thoughts in the past, but not in the last year, the doctor will need to talk to the study's medical monitor before you can join the trial.

I do not have any major health issues that could affect my safety or the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Emraclidine

Trial Overview 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.

How Is the Trial Designed?

Group I: Severe Renal Impairment Experimental Treatment 1 Intervention

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

Group II: Normal Renal Function Experimental Treatment 1 Intervention

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

Group III: Moderate Renal Impairment Experimental Treatment 1 Intervention

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

Group IV: Mild Renal Impairment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

Published Research Related to This Trial

In a study of 625 patients aged 66 and older, those with renal impairment experienced a greater decrease in platelet count while on linezolid, but the risk of severe thrombocytopenia was not significantly different from those without renal impairment.

The findings suggest that linezolid can be safely used in patients with renal impairment without the need for dose adjustments or drug level monitoring, as no significant differences in severe adverse effects were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Linezolid in Older Adults With Renal Impairment: A Population-Based Retrospective Cohort Study. Bai, AD., McKenna, S., Wise, H., et al.[2023]

In a study involving 55 HIV-infected adults with end-stage renal disease on chronic haemodialysis, the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide was found to be well tolerated over 48 weeks, with only 33% experiencing grade 3 or higher adverse events, none of which were deemed treatment-related.

The regimen offers a convenient treatment option for managing HIV-1 infection in this population, as it simplifies the complex medication regimens typically required for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Eron, JJ., Lelievre, JD., Kalayjian, R., et al.[2022]

In a study of 33 HIV-1-infected patients with mild-to-moderate renal impairment, the combination treatment of elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) achieved a high virologic success rate of 78.8% after 48 weeks, indicating its efficacy in this population.

The treatment was well tolerated, with only four patients discontinuing due to adverse events, and no cases of proximal renal tubulopathy were reported, suggesting a favorable renal safety profile similar to that observed in patients with better kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-infected patients with mild-to-moderate renal impairment. Post, FA., Winston, J., Andrade-Villanueva, JF., et al.[2021]

Cephaloridine has a serum half-life of approximately 1.56 hours after intravenous and 1.63 hours after intramuscular administration in normal subjects, indicating a relatively quick elimination from the body.

The study established a correlation between the elimination rate of cephaloridine and kidney function, allowing for tailored dosage regimens based on individual creatinine clearance, which is crucial for patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjustment of cephaloridine (Keflodin): dosage according to its pharmacokinetics. Brogard, JM., Brandt, C., Dorner, M., et al.[2018]

In patients with renal failure, the half-life of ceftizoxime (Cef) is significantly prolonged, averaging 15 hours, which is about 10 times longer than in healthy individuals.

Due to this extended half-life, it is crucial to adjust the clinical regimen for administering Cef in renal failure patients, either by increasing the time between doses or reducing the dosage to avoid potential toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of ceftizoxime in renal failure patients without dialysis. Li, P., Cai, Q., Gao, S., et al.[2013]

In a study of 122 patients treated for MRSA infection with either brand or generic vancomycin, there was no significant difference in the incidence of decreased renal function between the two products, suggesting similar safety profiles.

Although patients receiving the generic vancomycin received higher doses, the majority of renal function issues were linked to improper dosing rather than the type of vancomycin product used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Frequency of decreased renal function between patients treated with brand and generic products of vancomycin hydrochloride injection]. Izuwa, Y., Ueshima, S., Sato, T., et al.[2019]

In a study involving 31 subjects (7 with normal renal function and 24 with varying degrees of renal impairment), famotidine's half-life increased significantly with worsening kidney function, from 2.59 hours in normal subjects to 12.07 hours in those with severe renal failure.

The study recommends adjusting famotidine dosages based on kidney function: normal doses for those with creatinine clearance above 60 ml/min, half the dose for 60-30 ml/min, and a three-quarters reduction for those below 30 ml/min, ensuring safety in patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of famotidine, a new H2-receptor antagonist, in relation to renal function. Takabatake, T., Ohta, H., Maekawa, M., et al.[2019]

In a study of 132 patients with stages 2-4 chronic kidney disease, atorvastatin treatment showed a trend towards a slower decline in kidney function compared to placebo, although the results were not statistically significant.

The findings suggest that atorvastatin may have a potential renoprotective effect in patients with chronic kidney disease, particularly those with cardiovascular disease, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of atorvastatin on kidney function in chronic kidney disease: a randomised double-blind placebo-controlled trial. Fassett, RG., Robertson, IK., Ball, MJ., et al.[2022]

In a study of 143 urological patients, the optimal dose of vancomycin (VCM) for treating methicillin-resistant Staphylococcus aureus infections was found to vary based on the patient's estimated glomerular filtration rate (eGFR), indicating the need for dose adjustments in patients with renal dysfunction.

The analysis revealed significant correlations between VCM dose and trough levels in patients with eGFRs of 30-60 ml/min and 60-90 ml/min, suggesting that monitoring kidney function is crucial for effective and safe vancomycin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal vancomycin doses for methicillin-resistant Staphylococcus aureus infection in urological renal dysfunction patients. Shigemura, K., Osawa, K., Yamamichi, F., et al.[2018]

In a study of 91 patients with gram-positive bacterial infections, those with end-stage renal disease (ESRD) experienced significantly higher rates of severe thrombocytopenia (78.6%) and anemia (71.4%) compared to those without ESRD, indicating lower tolerability of linezolid in this group.

ESRD was identified as an independent risk factor for both thrombocytopenia and anemia, leading to more frequent treatment discontinuation due to these adverse effects compared to patients with non-end-stage renal disease (NESRD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High frequency of linezolid-associated thrombocytopenia and anemia among patients with end-stage renal disease. Wu, VC., Wang, YT., Wang, CY., et al.[2022]

In a study involving 26 healthy subjects and those with varying degrees of renal impairment, PD 0200390 was found to be rapidly absorbed, with its pharmacokinetics significantly affected by renal function, indicating that dose adjustments may be necessary for individuals with renal impairment.

The drug was well tolerated across all groups, although adverse events like somnolence, dizziness, and headache were more intense in subjects with severe renal impairment, highlighting the importance of monitoring side effects in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of renal impairment on the pharmacokinetics of PD 0200390, a novel ligand for the voltage-gated calcium channel alpha-2-delta subunit. Corrigan, B., Feltner, DE., Ouellet, D., et al.[2021]

Cefsulodin's elimination kinetics vary significantly based on renal function, with a half-life increasing from 1.9 hours in normal subjects to 13.0 hours in anuric patients, indicating that renal failure greatly affects the drug's clearance.

For patients undergoing hemodialysis, the maintenance dose of cefsulodin should be reduced to 10% of the normal dose, with an additional 60% of the dose administered after dialysis to account for the significant reduction in plasma drug concentration during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefsulodin kinetics in renal impairment. Gibson, TP., Granneman, GR., Kallal, JE., et al.[2019]

Cephaloridine effectively eradicated infections caused by Staphylococcus pyogenes and certain urinary tract infections due to Escherichia coli and Aerobacter aerogenes in a study of 30 patients, including 19 with renal impairment.

The antibiotic showed no significant adverse effects, even in patients with a history of penicillin allergies, making it a safe option for treating infections in individuals with renal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial of cephaloridine. Ruedy, J.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05940402

NCT05940402 | A Study to Evaluate Pharmacokinetic and ... The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-231-SP-1007

A Study to Evaluate Pharmacokinetic and Safety Trial of ... The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single ...

3. drugpatentwatch.com drugpatentwatch.com/p/drugs-in-development/drugname/CVL-231?srsltid=AfmBOoqcNy7jeRn4aLSqGUA7yLOpewsSj7lNlplkd9C53YjoMOwVO1Mn

CVL-231 clinical trial progress and patents: Drug pipeline ... A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function ...

4. withpower.com withpower.com/trial/phase-1-renal-insufficiency-6-2023-a232f

Emraclidine for Renal Impairment · Info for Participants This trial is testing a medication called emraclidine to see how it behaves in people with different levels of kidney function.

5. trial.medpath.com trial.medpath.com/drug/061720bd5ac0ff2f/emraclidine

Emraclidine | MedPath A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal ...

6. drugpatentwatch.com drugpatentwatch.com/p/drugs-in-development/drugname/CVL-231?srsltid=AfmBOop6xPPMccAVrdACEYmo_Z0mXs01GQj1tk-ihbguRV10MdrVomef

CVL-231 clinical trial progress and patents: Drug pipeline ... A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=31e423bd-096d-4a55-901e-bbf9a1c6d4da

emraclidine (CVL-231) / AbbVie A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function ...