Chronic Renal InsufficiencyPhase 1ApiDPNCT04006093
Apixaban in Subjects With Peritoneal Dialysis
A Phase 1 study testing Apixaban single dose 5mg in people with Chronic Renal Insufficiency and Peritoneal Dialysis, run by University Hospital, Caen at 1 site in France.
Trial summary
The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Renal Insufficiency, Peritoneal Dialysis
- What is being tested?
- Apixaban single dose 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2019to 10 Dec 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant with 21<BMI<40
- French participant
- Participant able to consent
- Participant with social insurance
- Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated
Who cannot join
- Participant with hypersensibility reactions to apixaban
- Participant with a history of major bleeding
- Participant already on anticoagulant
- Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage > 300 mg
- Participant on potent inhibitors of CYP 3A4 and P-gp
- Participant on inducers of CYP3A4 and P-sp
Show all 12Show fewer
- Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- Participant receiving or having received antibiotic treatment within 14 days prior to study
- Pregnant or lactating women
- Participant with known hypersensitivity reactions to icodextrin
- Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)
- Participant with "Normal renal function" with glomerular filtration rate < 90 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study
The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.
Read the detailed description
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.
- Conditions
- Chronic Renal Insufficiency, Peritoneal Dialysis
- Being tested
- Apixaban single dose 5mg
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban single dose 5mgDrug
Apixaban oral single dose 5mg
| Study group | Role | What they receive |
|---|---|---|
| Participants in peritoneal dialysis | Experimental | apixaban single dose 5mg in participants in peritoneal dialysis Receives: Drug: Apixaban single dose 5mg |
| Participants with normal renal function | Experimental | apixaban single dose 5mg in participants with normal renal function Receives: Drug: Apixaban single dose 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apixaban area Under the curve
Measurement of apixaban plasma concentrations at different times.
Measured: Day 3
Apixaban maximum plasma concentration
Measurement of apixaban plasma concentrations at different times.
Measured: Day 3
Secondary outcomes (5)
anti-Xa activity
anti-Xa activity plasma measurements
Measured: Hour 0, Hour 3, Hour 9 and Hour 72
TP activity
TP activity plasma measurements
Measured: Hour 0, Hour 3, Hour 9 and Hour 72
TCA activity
TCA activity plasma measurements
Measured: Hour 0, Hour 3, Hour 9 and Hour 72
Apixaban urinary elimination
Measurement of apixaban urinary concentrations
Measured: Day 3
Apixaban maximum peritoneal concentration
Measurement of apixaban peritoneal fluid concentrations
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start8 Dec 2019
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Model description
- Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006093
- Sponsor's protocol ID
- 19-060
- Acronym
- ApiDP
- Status last verified
- Apr 2019
- First submitted
- 5 Jun 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the trial has finished and the main trial paper has been published, a fully anonymised trial data set will be available on reasonable request from Clinical Research Unit of University Hospital of Caen, Normandy, France
Publications
Peyro-Saint-Paul L, Bechade C, Cesbron A, Debruyne D, Brionne M, Brucato S, Hanoy M, Dumont A, Briant AR, Parienti JJ, Lobbedez T, Ficheux M. Effect of peritoneal dialysis in end-stage renal disease on apixaban pharmacokinetics. Nephrol Dial Transplant. 2023 Jul 31;38(8):1918-1920. doi: 10.1093/ndt/gfad087. No abstract available.
PubMed 37169987
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Apixaban in Subjects With End-stage Renal Disease Treated With Peritoneal Dialysis: the ApiDP Study
- ClinicalTrials.gov ID
- NCT04006093
- Acronym / sponsor ID
- ApiDP / 19-060
- Conditions
- Chronic Renal Insufficiency, Peritoneal Dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- 8 Dec 2019 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 2 Jul 2019 (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 primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.
Detailed description
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.
| Arm | Type | Receives |
|---|---|---|
| Participants in peritoneal dialysis | Experimental | Drug: Apixaban single dose 5mgapixaban single dose 5mg in participants in peritoneal dialysis |
| Participants with normal renal function | Experimental | Drug: Apixaban single dose 5mgapixaban single dose 5mg in participants with normal renal function |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant with 21<BMI<40
- French participant
- Participant able to consent
- Participant with social insurance
- Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated
Key exclusion criteria (12 listed)
- Participant with hypersensibility reactions to apixaban
- Participant with a history of major bleeding
- Participant already on anticoagulant
- Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage > 300 mg
- Participant on potent inhibitors of CYP 3A4 and P-gp
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 |
|---|---|---|
| Apixaban single dose 5mgApixaban oral single dose 5mg | Drug | Participants in peritoneal dialysis, Participants with normal renal function |
Primary outcome
Apixaban area Under the curve
Time frame: Day 3
Measurement of apixaban plasma concentrations at different times.
Apixaban maximum plasma concentration
Time frame: Day 3
Measurement of apixaban plasma concentrations at different times.
5 secondary outcomes
anti-Xa activity
Time frame: Hour 0, Hour 3, Hour 9 and Hour 72
TP activity
Time frame: Hour 0, Hour 3, Hour 9 and Hour 72
TCA activity
Time frame: Hour 0, Hour 3, Hour 9 and Hour 72
Apixaban urinary elimination
Time frame: Day 3
Apixaban maximum peritoneal concentration
Time frame: day 3
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 Mar 2026.
- Results publication: PubMed 37169987Peyro-Saint-Paul L, Bechade C, Cesbron A, Debruyne D, Brionne M, Brucato S, Hanoy M, Dumont A, Briant AR, Parienti JJ, Lobbedez T, Ficheux M. Effect of peritoneal dialysis in end-stage renal disease on apixaban pharmacokinetics. Nephrol Dial Transplant. 2023 Jul 31;38(8):1918-1920. doi: 10.1093/ndt/gfad087. No abstract available.
- Individual participant dataSharing planned: Yes. Once the trial has finished and the main trial paper has been published, a fully anonymised trial data set will be available on reasonable request from Clinical Research Unit of University Hospital of Caen, Normandy, France
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apixaban single dose 5mg in people with Chronic Renal Insufficiency and Peritoneal Dialysis, run by University Hospital, Caen at 1 site in France.
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 5 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Apixaban area Under the curve (time frame: Day 3). The study lists 2 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 NCT04006093, 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 27 Mar 2026.