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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (VTE). Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min, will be safe and effective.
We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure (AKI) with intermittent hemodialysis (IHD) and 3) Acute renal failure with continuous renal replacement therapy (CRRT). All patients will be assessed for efficacy of the dose. Efficacy will be assessed by following clinically for any evidence of VTE, either deep venous thrombosis (DVT) or pulmonary embolism. In addition, lower extremity duplex studies will be performed at baseline and at the end of the study period to assess for DVT.
Secondary objectives will be safety and accumulation. Safety will be determined by assessment of clinically significant bleeding, defined as a drop in Hgb of > 2 grams (gm) in 24 hr, or the need for red blood cell transfusion related to bleeding. Accumulation may occur in renal failure and will be studied throughout the intensive care unit (ICU) stay through reevaluation of levels over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal failure on intermittent dialysis | Experimental | These are patients with renal failure, on intermittent hemodialysis (IHD), receiving fondaparinux 2.5 mg subcutaneously every 48 hours |
|
| Renal failure-renal replacement therapy | Experimental | These are patients with renal failure, either acute or chronic, on continuous renal replacement therapy (CRRT) receiving fondaparinux 2.5 mg subcutaneously every 48 hours |
|
| Renal failure, not on dialysis | Experimental | These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux | Drug | 2.5 mg every 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux. | Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period | Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven D Tennenberg, MD | WSU, DMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Failure, on Intermittent Hemodialysis (IHD) | These are patients with renal failure, on intermittent dialysis Fondaparinux: 2.5 mg every 48 hours |
| FG001 | Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours | These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours |
| FG002 | Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr | These are patients with acute kidney injury not yet on dialysis Fondaparinux: 2.5 mg every 48 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Failure, on Intermittent Hemodialysis (IHD) | These are patients with renal failure, on intermittent dialysis Fondaparinux: 2.5 mg every 48 hours |
| BG001 | Renal Failure, on CRRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux. | Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay. | Posted | Mean | Standard Deviation | mcg/ml | 2 years |
|
From study enrollment through until study discontinuation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Renal Failure, on Intermittent Hemodialysis (IHD) | These are patients with renal failure, on intermittent dialysis Fondaparinux: 2.5 mg every 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Significant Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Number of patients who experienced clinically significant bleeding |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Oozing (Minor Bleeding) | Blood and lymphatic system disorders | Non-systematic Assessment | Number of participants who experienced bleeding or oozing from lines, skin, hematuria, etc. None of these events were deemed clinically significant by the physician caring for the patient |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Wahby, Critical Care Pharmacist in the Medical ICU | Harper University Hospital | 313-745-2711 | kwahby@dmc.org |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D051437 | Renal Insufficiency |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| 2 years |
| Protocol Violation |
|
Fondaparinux: 2.5 mg every 48 hours
| BG002 | Renal Failure, Not on Dialysis | These are patients with acute kidney injury not yet on dialysis Fondaparinux: 2.5 mg every 48 hours |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours |
| OG002 | Renal Failure, Not on Dialysis | These are patients with acute kidney injury not yet on dialysis Fondaparinux: 2.5 mg every 48 hours |
|
|
| Secondary | To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period | Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study | Posted | Number | participants | 2 years |
|
|
|
| 1 |
| 16 |
| 2 |
| 16 |
| EG001 | Renal Failure-continuous Renal Replacement Therapy | These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours | 0 | 4 | 1 | 4 |
| EG002 | Renal Failure, Not on Dialysis | These are patients with acute kidney injury not yet on dialysis Fondaparinux: 2.5 mg every 48 hours | 0 | 12 | 2 | 12 |
|
| Venous Thromboembolism | Blood and lymphatic system disorders | Non-systematic Assessment | Number of patients who experienced a venous thromboembolism |
|
|
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| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |