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Anti-viral

AT-527 for Kidney Failure and Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Atea Pharmaceuticals, Inc.
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 day 1
Awards & highlights

Study Summary

This trial studied a new drug in people with healthy and impaired kidney function to see if it is safe and effective.

Who is the study for?
This trial is for adults willing to use two birth control methods and with a BMI of 18.5-42 kg/m2. It's not for pregnant or breastfeeding individuals, those with significant medical conditions, HIV/COVID-19, uncontrolled diabetes (HbA1c >10%), recent drug trials participants, or history of renal transplant.Check my eligibility
What is being tested?
The study tests AT-527 on people with different levels of kidney function. Some will also receive Probenecid. The goal is to understand how well AT-527 works in healthy subjects versus those with kidney impairment.See study design
What are the potential side effects?
While the specific side effects are not listed here, potential risks may include reactions related to kidney function changes due to the medication and interactions between AT-527 and Probenecid.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK) of AT-527 AUC
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Group E-Matched Healthy SubjectsExperimental Treatment1 Intervention
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
Group II: Group D-End-Stage Renal Disease (optional)Experimental Treatment1 Intervention
single dose of AT-527 pre- and post-dialysis
Group III: Group C-Severe Renal Impairment (optional)Experimental Treatment1 Intervention
single dose AT-527
Group IV: Group B-Moderate Renal ImpairmentExperimental Treatment1 Intervention
single dose AT-527
Group V: Group A-Mild Renal ImpairmentExperimental Treatment1 Intervention
single dose AT-527
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AT-527
2021
Completed Phase 2
~370

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Atea Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
3,996 Total Patients Enrolled

Media Library

AT-527 (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT05618314 — Phase 1
Kidney Failure Research Study Groups: Group A-Mild Renal Impairment, Group B-Moderate Renal Impairment, Group C-Severe Renal Impairment (optional), Group D-End-Stage Renal Disease (optional), Group E-Matched Healthy Subjects
Kidney Failure Clinical Trial 2023: AT-527 Highlights & Side Effects. Trial Name: NCT05618314 — Phase 1
AT-527 (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618314 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the population size for this clinical investigation?

"That is correct. Clinicaltrials.gov confirms that this research study, initially posted on October 17th 2022, is currently recruiting patients. Specifically, 36 participants need to be enrolled from a single trial site."

Answered by AI

Who qualifies to participate in this scientific research?

"This clinical trial seeks to recruit 36 individuals between the ages of 18 and 80 who are experiencing a decline in renal function. Participants must assent to using two forms of contraception from screening until 90 days after taking their final dose, present with a BMI ranging from 18.5 - 42 kg/m2, be medically healthy according to an investigator's opinion, have stable eGFRs between 15-90 mL/min/1.73 m2 for at least one month leading up to Screening (albeit End Stage Renal Disease patients may also apply), and provide written consent prior to participation."

Answered by AI

Is the patient recruitment for this experiment underway?

"The trial is currently recruiting, with the first posting on October 17th 2022 and most recent revision occurring on November 16th of that same year. This information may be accessed through clinicaltrials.gov."

Answered by AI

Are geriatric participants welcome to join this research study?

"This trial is limited to those between 18 and 80. There are 56 studies available for minors, while 523 trials exist open to seniors over 65 years of age."

Answered by AI

Has the FDA certified Group A-Mild Renal Impairment as a viable treatment?

"Our team's assessment gave Group A-Mild Renal Impairment a score of 1, reflecting the limited clinical data available to support safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of AT-527 in Subjects With Normal and Impaired Renal Function
2022. "Study of AT-527 in Subjects With Normal and Impaired Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05618314.
~14 spots leftby Apr 2025
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