Renal ImpairmentPhase 1NCT05992155

A Study of TAK-279 in Adults With or Without Kidney Problems

A Phase 1 study testing TAK-279 in people with Renal Impairment and Healthy Volunteers, run by Takeda at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with kidney problems compared to participants without kidney problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Renal Impairment, Healthy Volunteers
What is being tested?: TAK-279
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 27 Sep 2023to 28 May 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants with RI:
The participants must fulfill the following inclusion criteria to be eligible for participation in the study (participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the condition is resolved. Screening tests may be repeated if in the Investigator's opinion the test needs to be repeated):
Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Adult male or female participant aged ≥18 years, at screening.
Has a body weight greater than 50 kg and has a body mass index (BMI) ≥18.0 and ≤39.0 kilograms per meters squared (kg/m^2), at screening.
Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent [including electronic cigarettes]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.

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Aside from RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
Supine blood pressure (BP) is ≥90/40 mmHg (asymptomatic) and ≤180/100 mmHg, at screening;
Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening;
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin within the upper limit of normal (ULN) at screening and at check-in.
Creatine phosphokinase (CPK) ≤ ULN at the screening visit and at check-in.
Amylase and lipase ≤ ULN at the screening visit and at check-in.
Estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows,
Severe RI: <30 milliliters per minute (mL/min), not on dialysis;
Moderate RI: 30-59 mL/min.
Has chronic RI for at least 3 months before screening, and the RI must be stable, i.e., no significant changes (i.e., ≥30%) in renal function in the 30 days preceding screening (or since the last visit if within 6 months before screening) and treatment with stable doses of medication.
Female participants of childbearing potential agree to comply with highly effective contraceptive requirements of the protocol.
Male participants must agree to comply with effective contraceptive requirements of the protocol.
Healthy Participants:
Understands the study procedures in the ICF, and be willing and able to comply with the protocol.
Adult male or female participants aged ≥18 years, at screening. Participant will be matched by age (±10 years) and sex to a participant with severe RI (Part A) and/or a participant with moderate RI (Part B).
Has a body weight greater than 50 kg and has a BMI ≥18.0 and ≤39.0 kg/m2, at screening. Participant will be matched by body weight (±15 kg) to a participant with severe RI (Part A) and/or a participant with moderate RI (Part B).
Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent [including electronic cigarettes]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.
Medically healthy with no clinically significant medical history, physical examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
Supine BP is ≥90/40 mmHg and ≤150/95 mmHg, at screening;
Supine PR is ≥40 bpm and ≤99 bpm, at screening;
Liver function tests including ALT, AST, ALP, and total bilirubin within ULN at screening and at check-in.
CPK ≤ ULN at the screening visit and at check-in.
Amylase and lipase ≤ ULN at the screening visit and at check-in.
eGFR based on the MDRD equation at screening as follows:
Normal renal function: ≥90 mL/min.
Female participants of childbearing potential agree to comply with highly effective contraceptive requirements of the protocol.
Male participants must agree to comply with effective contraceptive requirements of the protocol.

Who cannot join

Participants with RI:
The participant must be excluded from participating in the study if the participant:
Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
Has history or presence of clinically significant medical or psychiatric condition or disease (aside from RI) in the opinion of the Investigator or designee.
Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
Has a history of any of the following:

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Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee;
Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing;
Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis);
An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing;
Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis);
Cancer or lymphoproliferative disease with the exception of successfully treated nonmelanoma skin cancer (NMSC) or basal cell carcinoma and/or localized carcinoma in situ of the cervix;
Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy;
Has had a failed renal transplant or a nephrectomy.
Has history or presence of alcoholism and/or drug abuse within the past 6 months prior to dosing, as determined by the Investigator or designee.
Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
Female with a positive pregnancy test at screening or check-in or who is lactating.
Has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the Investigator or designee.
Has positive results for the urine or saliva drug screen at screening or check-in, unless the positive drug screen is due to prescription drug use that is approved by the Investigator or designee and Sponsor.
Has positive results for urine or breath alcohol screen at screening or check-in.
Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements) for the prohibited time period.
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
Has made a donation of blood or had significant blood loss within 56 days prior to dosing.
Has made a plasma donation within 7 days prior to dosing.
Participated in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last dosing in the previous study to Day 1 of the current study.
Herpes infections:
Has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day -1.
History of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
Positive results for non-herpetic viral diseases at screening:
Hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV ribonucleic acid (RNA) (nucleic acid test or polymerase chain reaction (PCR));
Hepatitis B surface antigen (HBsAg)+, hepatitis B virus deoxyribonucleic acid (DNA), or anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-);
Human immunodeficiency virus (HIV).
Tuberculosis (TB):
History of active TB infection, regardless of treatment status;
Has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the Investigator or designee;
Has evidence of latent tuberculosis infection (LTBI) as evidenced by a positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis; Participant remains eligible if he or she can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines);
Has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB.
For Healthy Participants:
The participant must be excluded from participating in the study if the participant:
Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
Has history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
Has a history of any of the following:
Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee.
Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing.
Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing.
Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
Cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to dosing, as determined by the Investigator or designee.
Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
Female with a positive pregnancy test at screening or check-in, or who is lactating.
Has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if he or she participated in the study, in the opinion of the Investigator or designee.
Has positive results for the urine or saliva drug screen at screening or check-in, unless the positive drug screen is due to prescription drug use that is approved by the Investigator or designee and Sponsor.
Has positive results for urine or breath alcohol screen at screening or check-in.
Unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements) for the prohibited time period.
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
Has made a donation of blood or had significant blood loss within 56 days prior to dosing.
Has made a plasma donation within 7 days prior to dosing.
Participated in another clinical study within 30 days prior to dosing. The 30-day window will be derived from the date of the last dosing in the previous study to Day 1 of the current study.
Herpes infections:
Has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day -1.
History of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).
Positive results for non-herpetic viral diseases at screening:
HCV antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or PCR);
HBsAg+, hepatitis B virus DNA, or anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-);
HIV.
TB:
History of active TB infection, regardless of treatment status;
Has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the Investigator or designee;
Has evidence of LTBI as evidenced by a positive QFT result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis. Participant remains eligible if he or she can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines);
Has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Research by Design
Chicago, Illinois, 60643
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Renal Impairment

The participants will need to stay at the clinic for 11 days.

Read the detailed description

The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the pharmacokinetics (PK), safety, and tolerability of TAK-279 in participants with severe (Part A) and moderate (Part B) renal impairment (RI) compared to healthy participants with normal renal function.

The study will enroll up to 48 patients. Participants will be assigned to following study cohorts in Parts A and B to receive single-dose of TAK-279:

Cohort 1, Severe RI (12 participants): TAK-279 50 mg
Cohort 2, Normal Renal Function (12 to 24 participants): TAK-279 50 mg
Cohort 3, Moderate RI (12 participants): TAK-279 50 mg

If the decision to proceed to Part B is made, participants with moderate RI will be enrolled in Cohort 3 of the study. Participants in Cohort 3 will receive single-dose of TAK-279 50 mg and will be compared with the participants who meet the matching criteria of Cohort 2 with normal renal function. A participant with normal renal function (either from Part A or enrolled in Part B) may be matched to only one participant with RI in Part B.

This multi-center trial will be conducted in the United States. The overall duration of the study is up to 44 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.

Conditions: Renal Impairment, Healthy Volunteers
Being tested: TAK-279
Keywords: Drug Therapy
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-279Drug
TAK-279 capsules.

Study groups in NCT05992155
Study group	Role	What they receive
Cohort 1, Severe RI: TAK-279 50 mg	Experimental	Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Receives: Drug: TAK-279
Cohort 2, Normal Renal Function: TAK-279 50 mg	Experimental	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. Receives: Drug: TAK-279
Cohort 3, Moderate RI: TAK-279 50 mg	Experimental	Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study. Receives: Drug: TAK-279

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax: Maximum Observed Plasma Concentration for TAK-279
Measured: Predose to Day 10
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
Measured: Predose to Day 10
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Measured: Predose to Day 10

Secondary outcomes (6)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: From study start through 14 days after last dose administration (up to approximately 42 days)
Number of Participants With Adverse Events of Special Interest (AESIs)
Measured: From study start through 14 days after last dose administration (up to approximately 42 days)
Number of Participants With Markedly Abnormal Values for Vital Signs
Measured: Up to Day 10
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Measured: Up to Day 10
Number of Participants With Markedly Abnormal Laboratory Values
Measured: Up to Day 10
Number of Participants With Clinically Significant Physical Examination Findings
Measured: Up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202328 May 2024

First posted15 Aug 2023
Study start27 Sep 2023
Primary completion22 May 2024
Study completion28 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05992155
Sponsor's protocol ID: TAK-279-1003
Status last verified: Jun 2024
First submitted: 8 Aug 2023
Last updated: 27 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Renal Impairment
ClinicalTrials.gov ID: NCT05992155
Acronym / sponsor ID: TAK-279-1003
Conditions: Renal Impairment, Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 27 Sep 2023 (actual)
Primary completion: 22 May 2024 (actual)
Study completion: 28 May 2024 (actual)
First posted: 15 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The participants will need to stay at the clinic for 11 days.

Detailed description

The study will enroll up to 48 patients. Participants will be assigned to following study cohorts in Parts A and B to receive single-dose of TAK-279:

Cohort 1, Severe RI (12 participants): TAK-279 50 mg
Cohort 2, Normal Renal Function (12 to 24 participants): TAK-279 50 mg
Cohort 3, Moderate RI (12 participants): TAK-279 50 mg

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1, Severe RI: TAK-279 50 mg	Experimental	Drug: TAK-279Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Cohort 2, Normal Renal Function: TAK-279 50 mg	Experimental	Drug: TAK-279Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
Cohort 3, Moderate RI: TAK-279 50 mg	Experimental	Drug: TAK-279Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (33 listed)

Participants with RI:
The participants must fulfill the following inclusion criteria to be eligible for participation in the study (participants who do not qualify based on a reversible condition or mild intercurrent illness may be re-screened after the condition is resolved. Screening tests may be repeated if in the Investigator's opinion the test needs to be repeated):
Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
Adult male or female participant aged ≥18 years, at screening.
Has a body weight greater than 50 kg and has a body mass index (BMI) ≥18.0 and ≤39.0 kilograms per meters squared (kg/m^2), at screening.

Key exclusion criteria (73 listed)

Participants with RI:
Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
Has history or presence of clinically significant medical or psychiatric condition or disease (aside from RI) in the opinion of the Investigator or designee.
Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
Has a history of any of the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-279TAK-279 capsules.	Drug	Cohort 1, Severe RI: TAK-279 50 mg, Cohort 2, Normal Renal Function: TAK-279 50 mg, Cohort 3, Moderate RI: TAK-279 50 mg

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-279
Time frame: Predose to Day 10
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
Time frame: Predose to Day 10
AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
Time frame: Predose to Day 10

6 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From study start through 14 days after last dose administration (up to approximately 42 days)
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From study start through 14 days after last dose administration (up to approximately 42 days)
Number of Participants With Markedly Abnormal Values for Vital Signs
Time frame: Up to Day 10
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
Time frame: Up to Day 10
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: Up to Day 10
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: Up to Day 10

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
To obtain more information about this study, click this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-279 in people with Renal Impairment and Healthy Volunteers, run by Takeda at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 73 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for TAK-279 (time frame: Predose to Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05992155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.