Renal ImpairmentPhase 1NCT03296787

A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954

A Phase 1 study testing TAK-954 in people with Renal Impairment and Healthy Volunteers, run by Takeda at 4 sites in 2 countries.

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 purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment, Healthy Volunteers
What is being tested?: TAK-954
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 4 sitesin 2 countries
Study dates: 21 Nov 2017to 9 Aug 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2).
Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance [CLcr] greater than or equal to [>=] 90 milliliter per minute [mL/min]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent [%] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.
Group B: Participants with mild RI (CLcr 60 to less than [<] 90 mL/min).
Group C: Participants with moderate RI (CLcr 30 to <60 mL/min).
Group D: Participants with severe RI or ESRD but not requiring dialysis (CLcr <30 mL/min).
Group E: Participants with ESRD requiring dialysis (<15 mL/min requiring hemodialysis at least 3 times/week, and having been on the same dialysis treatment regimen for at least 1 month before trial entry).
Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.

Who cannot join

All participants:
Are renal allograft recipients within 1 year of screening.
Have a history of gastrointestinal (GI) motility disorder or intestinal obstruction.
Have urinary incontinence without catheterization.
Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
Groups B to E:

Show all 9Show fewer

Receive dialysis other than intermittent dialysis (except Group E).
Have renal disease secondary to hepatic disease (hepatorenal syndrome).
At the discretion of the investigators, have any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Czechia2 sites

Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
PRA CZ, s.r.o
Prague, Prague, 170 00

Other trials in Czechia

Hungary2 sites

PRA Magyarorszag Kft.
Budapest, 1077
Szent Imre Egyetemi Oktatokorhaz Belgyogyazati Szakmak Matrix Intezet
Budapest, 1115

Other trials in Hungary

About this study

Official title: A Phase 1, Open-Label, Parallel Group Trial to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single Intravenous Dose of TAK-954

Read the detailed description

The drug being tested in this study is called TAK-954. This study will evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

The study will enroll approximately up to 40 participants. Participants will be enrolled in one of the 5 treatment groups based on their renal impairment which will be determined based on Cockcroft and Gault (CG) equation as follows:

Group A TAK-954 0.2 mg: Healthy Participants
Group B TAK-954 0.2 mg: Mild Renal Impairment
Group C TAK-954 0.2 mg: Moderate Renal Impairment
Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.

Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.

This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to participate in this study is approximately 8 weeks. Participants in Groups A to D will remain confined to clinic for 3 days. For both treatments, participants in Group E requiring dialysis will remain confined to clinic for 3 days. All participants will make a final visit to the clinic 10-14 days after receiving their last dose for a follow-up assessment.

Conditions: Renal Impairment, Healthy Volunteers
Being tested: TAK-954
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-954Drug
TAK-954 intravenous infusion.

Study groups in NCT03296787
Study group	Role	What they receive
Group A TAK-954 0.2 mg: Healthy Participants	Experimental	Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period. Receives: Drug: TAK-954
Group B TAK-954 0.2 mg: Mild Renal Impairment	Experimental	Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. Receives: Drug: TAK-954
Group C TAK-954 0.2 mg: Moderate Renal Impairment	Experimental	Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. Receives: Drug: TAK-954
Group D TAK-954 0.2 mg: Severe Renal Impairment	Experimental	Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period. Receives: Drug: TAK-954
Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD)	Experimental	Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period. Receives: Drug: TAK-954

What is being measured

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

Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Measured: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
Measured: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
Measured: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
Measured: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; CLR: Renal Clearance for TAK-954
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 1
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 2
Measured: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2
Measured: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion

Timeline

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

21 Nov 20179 Aug 2019

First posted28 Sep 2017
Study start21 Nov 2017
Primary completion9 Aug 2019
Study completion9 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03296787
Sponsor's protocol ID: TAK-954-1007
Other IDs: U1111-1196-9206, 2017-000715-16, 2017
Status last verified: Aug 2020
First submitted: 25 Sep 2017
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Parallel Group Trial to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single Intravenous Dose of TAK-954
ClinicalTrials.gov ID: NCT03296787
Acronym / sponsor ID: TAK-954-1007
Conditions: Renal Impairment, Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 21 Nov 2017 (actual)
Primary completion: 9 Aug 2019 (actual)
Study completion: 9 Aug 2019 (actual)
First posted: 28 Sep 2017 (actual)
Results: Posted 25 Aug 2020

Clinical summary

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

Detailed description

Group A TAK-954 0.2 mg: Healthy Participants
Group B TAK-954 0.2 mg: Mild Renal Impairment
Group C TAK-954 0.2 mg: Moderate Renal Impairment
Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.

Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group A TAK-954 0.2 mg: Healthy Participants	Experimental	Drug: TAK-954Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
Group B TAK-954 0.2 mg: Mild Renal Impairment	Experimental	Drug: TAK-954Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
Group C TAK-954 0.2 mg: Moderate Renal Impairment	Experimental	Drug: TAK-954Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
Group D TAK-954 0.2 mg: Severe Renal Impairment	Experimental	Drug: TAK-954Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD)	Experimental	Drug: TAK-954Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2).
Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance [CLcr] greater than or equal to [>=] 90 milliliter per minute [mL/min]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent [%] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.
Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.

Key exclusion criteria (9 listed)

All participants:
Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
Groups B to E:

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-954TAK-954 intravenous infusion.	Drug	Group A TAK-954 0.2 mg: Healthy Participants, Group B TAK-954 0.2 mg: Mild Renal Impairment, Group C TAK-954 0.2 mg: Moderate Renal Impairment, Group D TAK-954 0.2 mg: Severe Renal Impairment, Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD)

Primary outcome

Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
Time frame: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; CLR: Renal Clearance for TAK-954
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 1
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 2
Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2
Time frame: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Healthy Participants	8	8
Group C: Moderate Renal Impairment	8	8
Group D: Severe Renal Impairment Not Requiring Dialysis	9	9
Group E: ESRD Requiring Dialysis	7	7

Primary outcome: Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)

Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Group A: Healthy Participants n = 8	Group C: Moderate Renal Impairment n = 8	Group D: Severe Renal Impairment Not Requiring Dialysis n = 8
TAK-954 (Total)	2.623 (12.8)	2.536 (23.2)	2.660 (17.6)
TAK-954 (Free)	0.1270 (29.2)	0.1282 (22.5)	0.1572 (21.7)

Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.7265, ANOVA
Group A: Healthy Participants vs Group D: Severe Renal Impairment Not Requiring Dialysis: p = 0.9839, ANOVA
Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.9393, ANOVA

Population analysed: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The outcome measure (OM) was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.

Primary outcome: Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)

Time frame: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Group A: Healthy Participants n = 8	Group C: Moderate Renal Impairment n = 8	Group D: Severe Renal Impairment Not Requiring Dialysis n = 8
TAK-954 (Total)	22.25 (19.1)	24.91 (22.9)	28.62 (18.1)
TAK-954 (Free)	1.078 (25.7)	1.259 (25.1)	1.690 (25.9)

Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.3600, ANOVA
Group A: Healthy Participants vs Group D: Severe Renal Impairment Not Requiring Dialysis: p = 0.0816, ANOVA
Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.2686, ANOVA

Population analysed: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The OM was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.

Primary outcome: Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)

Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Group A: Healthy Participants n = 8	Group C: Moderate Renal Impairment n = 8	Group D: Severe Renal Impairment Not Requiring Dialysis n = 8
TAK-954 (Total)	24.39 (17.7)	30.00 (20.0)	34.28 (19.3)
TAK-954 (Free)	1.184 (26.8)	1.516 (24.3)	2.025 (26.7)

Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.0998, ANOVA
Group A: Healthy Participants vs Group D: Severe Renal Impairment Not Requiring Dialysis: p = 0.0155, ANOVA
Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.0916, ANOVA

Population analysed: The PK set consisted of all participants who were enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. The OM was planned to be assessed for the groups where blood samples were collected before the start of TAK-954 infusion and through 120 hours post-infusion.

Primary outcome: Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)

Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Group A: Healthy Participants n = 8	Group C: Moderate Renal Impairment n = 7	Group D: Severe Renal Impairment Not Requiring Dialysis n = 7
TAK-954 (Total)	25.43 (16.8)	34.90 (16.2)	38.59 (23.9)
TAK-954 (Free)	1.234 (28.4)	1.749 (24.8)	2.320 (29.7)

Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.0038, ANOVA
Group A: Healthy Participants vs Group D: Severe Renal Impairment Not Requiring Dialysis: p = 0.0004, ANOVA
Group A: Healthy Participants vs Group C: Moderate Renal Impairment: p = 0.0389, ANOVA

Population analysed: PK set:participants who enrolled and received at least 1 dose of trial drug and had at least 1 measurable TAK-954 plasma concentration. Here,"overall number of participants analyzed": participants who were evaluable for this OM. OM was planned to be assessed in groups where blood samples collected pre-TAK-954 infusion up to 120 hours post-infusion.

Adverse events

Time frame: Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug as Treatment 2 (up to Day 29) in Group A, C, and E), and Treatment 1 (up to Day 15) in for Group D. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Healthy Participants	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Group C: Moderate Renal Impairment	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Group D: Severe Renal Impairment Not Requiring Dialysis	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Group E: ESRD 1 Hour After Dialysis	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Group E: ESRD 2 Hours Before Dialysis	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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End Stage Renal Disease (ESRD), Kidney Transplant

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.

Medical Director study director

Takeda

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-954 in people with Renal Impairment and Healthy Volunteers, run by Takeda at 4 sites in 2 countries.

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 8 inclusion and 9 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia, Hungary. 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?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free) (time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion). The study lists 14 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 NCT03296787.

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 25 Aug 2020.