Kidney Failure, ChronicPhase 1NCT02022748

Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects

A Phase 1 study testing ticagrelor in people with Kidney Failure, Chronic, run by AstraZeneca at 2 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

A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal function. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: ticagrelor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: 29 Dec 2013to 9 May 2016
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or Female aged 18 to 80 years (inclusive).
Normal renal function (CrCl of ≥90 mL/min) or End Stage Renal Disease (ESRD) requiring hemodialysis.

Who cannot join

Any indication for oral anticoagulant or anti platelet treatment during study period. Must be off treatment for at least 3 weeks (low dose 81mg aspirin is allowed for hemodialysis subjects only).
Acute Coronary Syndrome (ACS) within past 12 months.
Contraindications to ticagrelor (ie: active pathological bleeding, severe hepatic impairment, history of hemorrhagic stroke, allergic to ticagrelor).
Platelet count <100000/μL, hemoglobin <9g/dL
Blood donation within 90 days of dosing
Risk for bradycardia

Show all 12Show fewer

Investigational drug within 30 days or 6 half-lives, whichever is longer, before dosing
Concomitant therapy with CYP3A inhibitors/substrates with narrow therapeutic index,or strong CYP3A inducers 14 days before dosing until completion of the follow-up visit.
History of alcohol, drug, or substance abuse within the past year
Clinically significant laboratory abnormalities as judged by the investigator.
Increased bleeding risk including GI bleeding in past 30 days; history of intracranial, retroperitoneal, or spinal bleeding, recent major trauma within 30 days of dosing, Sustained uncontrolled hypertension, history of hemorrhagic disorders.
Pregnant or lactating females, or females of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopause) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator throughout the duration of the study OR females who have a positive pregnancy test at Visit 1.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Lakewood, Colorado, 80228
Research Site
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Single Dose, Randomized, Open-Label, Parallel Group Study Comparing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ticagrelor in Hemodialysis Patients to Subjects With Normal Renal Function

A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal function.

Read the detailed description

This will be a single dose, randomised, open label, parallel group study conducted in the US to examine the Pharmacokinetics (PK), Pharmacodynamics (PD), safety, and tolerability of ticagrelor in end stage renal disease (ESRD) subjects on hemodialysis (HD) compared with healthy subjects with normal renal function. Up to a total of 30 male and female adult subjects aged 18 to 80 years (inclusive) with a weight of at least 50 kg and a body mass index between 18 and 40 kg/m2 (inclusive), will be dosed to assure that there will be 20 evaluable subjects (10 subjects on HD and in 10 healthy subjects with normal renal function (CrCL ≥90 mL/min). The normal renal function groups should have a similar distribution with respect to age, weight and gender. Subjects will be required to have an inpatient stay from the day prior to dosing until the 48-hour post-dose time-point to ensure that all PK samples are collected at the appropriate timepoints. The study will be conducted in two groups: Group A consisting of ESRD subjects on HD, Group B consisting of healthy subjects. A crossover design will be implemented for Group A subjects as follows: Group A subjects will be randomized into two sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will receive treatment A in Period 1 and treatment B in Period 2. There will be washout period of at least 7 days between Period 1 and Period 2 in Sequence 1. Similarly in Sequence 2, subjects will receive treatment B in Period 1 and treatment A in Period 2. There will be a washout period of at least 7 days between Period 1 and Period 2 in Sequence 2 as well. Treatment A and treatment B are defined as follows: Treatment A: subjects will be dosed with an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session; • Treatment B: subjects will be dosed with an oral 90 mg ticagrelor tablet just prior to dialysis session.(NB: Treatment B dosing should occur within 5 minutes of dialysis start). Group B subjects (healthy subjects) with normal renal function (CrCL of ≥ 90 mL/min) will receive just an oral 90 mg ticagrelor referred to as treatment H. All doses will be administered in an open-label design.

Conditions: Kidney Failure, Chronic
Being tested: ticagrelor
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

ticagrelorDrug
Also called Brilinta
Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will receive treatment A in Period 1 and treatment B in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 1. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.
ticagrelorDrug
Also called Brilinta
Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 2, subjects will receive treatment B in Period 1 and treatment A in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 2. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.
ticagrelorDrug
Also called Brilinta
Group B is healthy subjects. Group B healthy subjects will receive oral 90 mg ticagrelor referred to as Treatment H.

Study groups in NCT02022748
Study group	Role	What they receive
Sequence 1	Experimental	hemodialysis patients: subjects will receive treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 1 and treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 2. Receives: Drug: ticagrelor
Sequence 2	Experimental	hemodialysis patients: subjects will receive treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 1 and treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 2. Receives: Drug: ticagrelor
Treatment H	Experimental	Healthy subjects: ticagrelor oral 90 mg on 1 day of treatment Receives: Drug: ticagrelor

What is being measured

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

Pharmacokinetic Parameter Cmax of Ticagrelor
Measured: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter Cmax of AR-C124910XX
Measured: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor
Measured: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX
Measured: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose

Secondary outcomes (2)

Pharmacokinetic Parameter t1/2 of Ticagrelor
Measured: 3 days
Pharmacokinetic Parameter t1/2 of AR-C124910XX
Measured: 3 days

Timeline

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

29 Dec 20139 May 2016

First posted30 Dec 2013 (estimated)
Study start29 Dec 2013
Primary completion9 May 2016
Study completion9 May 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02022748
Sponsor's protocol ID: D5130L00067
Status last verified: Jan 2018
First submitted: 22 Dec 2013
Last updated: 17 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
PubMed 35224730

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 Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose, Randomized, Open-Label, Parallel Group Study Comparing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ticagrelor in Hemodialysis Patients to Subjects With Normal Renal Function
ClinicalTrials.gov ID: NCT02022748
Acronym / sponsor ID: D5130L00067
Conditions: Kidney Failure, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 29 Dec 2013 (actual)
Primary completion: 9 May 2016 (actual)
Study completion: 9 May 2016 (actual)
First posted: 30 Dec 2013 (estimated)
Results: Posted 29 Sep 2017

Clinical summary

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

A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal function.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sequence 1	Experimental	Drug: ticagrelorhemodialysis patients: subjects will receive treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 1 and treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 2.
Sequence 2	Experimental	Drug: ticagrelorhemodialysis patients: subjects will receive treatment B (ticagrelor oral 90 mg just prior to dialysis session) in period 1 and treatment A (ticagrelor oral 90 mg 1 day following the dialysis session but 2 days before the next dialysis session) in period 2.
Treatment H	Experimental	Drug: ticagrelorHealthy subjects: ticagrelor oral 90 mg on 1 day of treatment

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or Female aged 18 to 80 years (inclusive).
Normal renal function (CrCl of ≥90 mL/min) or End Stage Renal Disease (ESRD) requiring hemodialysis.

Key exclusion criteria (12 listed)

Any indication for oral anticoagulant or anti platelet treatment during study period. Must be off treatment for at least 3 weeks (low dose 81mg aspirin is allowed for hemodialysis subjects only).
Acute Coronary Syndrome (ACS) within past 12 months.
Contraindications to ticagrelor (ie: active pathological bleeding, severe hepatic impairment, history of hemorrhagic stroke, allergic to ticagrelor).
Platelet count <100000/μL, hemoglobin <9g/dL
Blood donation within 90 days of dosing

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
ticagrelorAlso: BrilintaGroup A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will receive treatment A in Period 1 and treatment B in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 1. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.	Drug	Sequence 1
ticagrelorAlso: BrilintaGroup A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 2, subjects will receive treatment B in Period 1 and treatment A in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 2. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.	Drug	Sequence 2
ticagrelorAlso: BrilintaGroup B is healthy subjects. Group B healthy subjects will receive oral 90 mg ticagrelor referred to as Treatment H.	Drug	Treatment H

Primary outcome

Pharmacokinetic Parameter Cmax of Ticagrelor
Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter Cmax of AR-C124910XX
Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor
Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX
Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose

2 secondary outcomes

Pharmacokinetic Parameter t1/2 of Ticagrelor
Time frame: 3 days
Pharmacokinetic Parameter t1/2 of AR-C124910XX
Time frame: 3 days

Results and safety

Results posted to the registry on 29 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (AB)	8	7
Sequence 2 (BA)	6	4
Treatment H	13	13

Primary outcome: Pharmacokinetic Parameter Cmax of Ticagrelor

Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 12	Treatment B n = 13	Treatment H n = 13
Value	560.32 (54.0)	598.35 (47.9)	370.76 (37.3)

Treatment A vs Treatment H: Ratio of Geometric Least Square Means: 151.13 (90% CI 112.03 to 203.86)
Treatment B vs Treatment H: Ratio of Geometric Least Square Means: 161.38 (90% CI 122.52 to 212.58)
Treatment A vs Treatment B: Ratio of Geometric Least Square Means: 90.10 (90% CI 78.07 to 103.98)

Population analysed: The Pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.

Primary outcome: Pharmacokinetic Parameter Cmax of AR-C124910XX

Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 12	Treatment B n = 13	Treatment H n = 13
Value	130.82 (38.3)	152.25 (54.3)	111.73 (60.0)

Treatment A vs Treatment H: Ratio of Geometric Least Square Means: 117.09 (90% CI 84.51 to 162.22)
Treatment B vs Treatment H: Ratio of Geometric Least Square Means: 136.27 (90% CI 95.38 to 194.70)
Treatment A vs Treatment B: Ratio of Geometric Least Square Means: 82.29 (90% CI 68.43 to 98.96)

Population analysed: The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.

Primary outcome: Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor

Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment A n = 12	Treatment B n = 13	Treatment H n = 13
Value	3015.1 (54.2)	3256.1 (52.5)	2188.8 (22.6)

Treatment A vs Treatment H: Ratio of Geometric Least Square Means: 137.75 (90% CI 105.70 to 179.52)
Treatment B vs Treatment H: Ratio of Geometric Least Square Means: 148.76 (90% CI 115.07 to 192.32)
Treatment A vs Treatment B: Ratio of Geometric Least Square Means: 90.35 (90% CI 77.55 to 105.27)

Primary outcome: Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX

Time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment A n = 12	Treatment B n = 13	Treatment H n = 13
Value	1127.8 (39.3)	1144.2 (36.2)	1000.4 (33.2)

Treatment A vs Treatment H: Ratio of Geometric Least Square Means: 112.73 (90% CI 88.61 to 143.42)
Treatment B vs Treatment H: Ratio of Geometric Least Square Means: 114.37 (90% CI 91.19 to 143.45)
Treatment A vs Treatment B: Ratio of Geometric Least Square Means: 93.13 (90% CI 80.31 to 108.00)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Starting from the date of first dose of study medication to follow-up (5-10 days post discharge unit). For HD Subjects, events that occurred during the washout or follow-up periods are attributed to the previous treatment taken.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Treatment B	1 of 13 (7.7%)	3 of 13 (23.1%)	Not reported
Treatment H	0 of 13 (0%)	2 of 13 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35224730Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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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.

Jolene K Berg, MD principal investigator

DaVita Clinical Research, Minneapolis, MN

2 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 ticagrelor in people with Kidney Failure, Chronic, run by AstraZeneca at 2 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 2 inclusion and 12 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 29 Sep 2017). 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?

Pharmacokinetic Parameter Cmax of Ticagrelor (time frame: 0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose). The study lists 4 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 NCT02022748, which also lists 1 linked publication.

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 17 Jan 2018.