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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
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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.
Participants with chronic renal disease treated with peritoneal dialysis and participants with normal renal function are hospitalized for three days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants in peritoneal dialysis | Experimental | apixaban single dose 5mg in participants in peritoneal dialysis |
|
| Participants with normal renal function | Experimental | apixaban single dose 5mg in participants with normal renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban single dose 5mg | Drug | Apixaban oral single dose 5mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apixaban area Under the curve | Measurement of apixaban plasma concentrations at different times. | Day 3 |
| Apixaban maximum plasma concentration | Measurement of apixaban plasma concentrations at different times. | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| anti-Xa activity | anti-Xa activity plasma measurements | Hour 0, Hour 3, Hour 9 and Hour 72 |
| TP activity | TP activity plasma measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | 14000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37169987 | Result | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2022 | Feb 10, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2023 | Mar 25, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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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.
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| Hour 0, Hour 3, Hour 9 and Hour 72 |
| TCA activity | TCA activity plasma measurements | Hour 0, Hour 3, Hour 9 and Hour 72 |
| Apixaban urinary elimination | Measurement of apixaban urinary concentrations | Day 3 |
| Apixaban maximum peritoneal concentration | Measurement of apixaban peritoneal fluid concentrations | day 3 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |