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TAK-279 for Kidney Problems

Phase 1
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with RI must be adult male or female aged ≥18 years, with a body weight greater than 50 kg and a body mass index (BMI) ≥18.0 and ≤39.0 kg/m^2
Healthy participants must be adult male or female aged ≥18 years, with a body weight greater than 50 kg and a BMI ≥18.0 and ≤39.0 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start through 14 days after last dose administration (up to approximately 42 days)
Awards & highlights

Study Summary

This trial will compare how kidney disease affects how the body processes a medicine, TAK-279, and its potential side effects. Patients stay at the clinic for 11 days.

Who is the study for?
This trial is for adults over 18 years old with stable kidney problems or healthy individuals, both non-smokers or moderate smokers. Participants must understand the study and be able to follow its rules. They should not have significant medical conditions aside from kidney issues, recent infections, fevers, or a history of cancer within the last five years.Check my eligibility
What is being tested?
The study tests how a single dose of TAK-279 is processed in people with kidney problems compared to those without. It aims to identify side effects and assess tolerance levels of TAK-279 after an 11-day clinic stay.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial will monitor participants for any adverse reactions to TAK-279 during their clinic stay.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18, weigh more than 50 kg, and my BMI is between 18.0 and 39.0.
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I am an adult over 18, weigh more than 50 kg, and my BMI is between 18.0 and 39.0.
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I am healthy with no significant medical history or abnormal test results.
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I am a non-smoker or smoke 10 or fewer cigarettes a day.
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My kidney disease has been stable for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start through 14 days after last dose administration (up to approximately 42 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start through 14 days after last dose administration (up to approximately 42 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Cmax: Maximum Observed Plasma Concentration for TAK-279
Secondary outcome measures
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Number of Participants With Clinically Significant Physical Examination Findings
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3, Moderate RI: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study.
Group II: Cohort 2, Normal Renal Function: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Group III: Cohort 1, Severe RI: TAK-279 50 mgExperimental Treatment1 Intervention
Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~180

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,896 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,224 Total Patients Enrolled

Media Library

TAK-279 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05992155 — Phase 1
Healthy Subjects Research Study Groups: Cohort 1, Severe RI: TAK-279 50 mg, Cohort 3, Moderate RI: TAK-279 50 mg, Cohort 2, Normal Renal Function: TAK-279 50 mg
Healthy Subjects Clinical Trial 2023: TAK-279 Highlights & Side Effects. Trial Name: NCT05992155 — Phase 1
TAK-279 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05992155 — Phase 1

Frequently Asked Questions

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

Are there any open recruitment opportunities for the clinical trial?

"The information hosted on clinicaltrials.gov reveals that this study has ceased to accept new participants, as it was last updated on August 8th 2023. Despite the inactivity of this particular trial, 974 other medical trials are currently enrolling patients at present."

Answered by AI

Has the FDA sanctioned the use of TAK-279 50 mg for Cohort 1, Severe RI patients?

"Since this is a Phase 1 trial, meaning there are only limited data supporting its efficacy and safety, Cohort 1, Severe RI: TAK-279 50 mg received an estimated score of 1."

Answered by AI

Who else is applying?

What site did they apply to?
Orlando Clinical Research Center
Research by Design
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-279 in Adults With or Without Kidney Problems
2023. "A Study of TAK-279 in Adults With or Without Kidney Problems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05992155.
~26 spots leftby Jan 2025
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