Trial Outcomes & Findings for Fondaparinux in Critically Ill Patients With Renal Failure (NCT NCT01467583)
NCT ID: NCT01467583
Last Updated: 2015-06-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
2 years
Results posted on
2015-06-19
Participant Flow
Participant milestones
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
12
|
|
Overall Study
COMPLETED
|
14
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
Baseline Characteristics
Fondaparinux in Critically Ill Patients With Renal Failure
Baseline characteristics by cohort
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
n=16 Participants
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, on CRRT
n=4 Participants
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, Not on Dialysis
n=12 Participants
These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 12 • n=5 Participants
|
63 years
STANDARD_DEVIATION 10 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
62 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
32 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsFondaparinux 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.
Outcome measures
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
n=16 Participants
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure-continuous Renal Replacement Therapy
n=4 Participants
These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, Not on Dialysis
n=12 Participants
These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours
|
|---|---|---|---|
|
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.
Peak Levels
|
0.42 mcg/ml
Standard Deviation 0.16
|
0.31 mcg/ml
Standard Deviation 0.13
|
0.37 mcg/ml
Standard Deviation 0.21
|
|
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.
Trough Levels
|
0.18 mcg/ml
Standard Deviation 0.1
|
0.12 mcg/ml
Standard Deviation 0.09
|
0.17 mcg/ml
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 2 yearsSafety 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
Outcome measures
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
n=16 Participants
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure-continuous Renal Replacement Therapy
n=4 Participants
These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, Not on Dialysis
n=12 Participants
These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours
|
|---|---|---|---|
|
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
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Renal Failure, on Intermittent Hemodialysis (IHD)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Renal Failure-continuous Renal Replacement Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Renal Failure, Not on Dialysis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
n=16 participants at risk
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure-continuous Renal Replacement Therapy
n=4 participants at risk
These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, Not on Dialysis
n=12 participants at risk
These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Clinically Significant Bleeding
|
6.2%
1/16 • Number of events 1 • From study enrollment through until study discontinuation
|
0.00%
0/4 • From study enrollment through until study discontinuation
|
0.00%
0/12 • From study enrollment through until study discontinuation
|
|
Blood and lymphatic system disorders
Venous Thromboembolism
|
0.00%
0/16 • From study enrollment through until study discontinuation
|
0.00%
0/4 • From study enrollment through until study discontinuation
|
0.00%
0/12 • From study enrollment through until study discontinuation
|
Other adverse events
| Measure |
Renal Failure, on Intermittent Hemodialysis (IHD)
n=16 participants at risk
These are patients with renal failure, on intermittent dialysis
Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure-continuous Renal Replacement Therapy
n=4 participants at risk
These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
|
Renal Failure, Not on Dialysis
n=12 participants at risk
These are patients with acute kidney injury not yet on dialysis
Fondaparinux: 2.5 mg every 48 hours
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Minor Oozing (Minor Bleeding)
|
12.5%
2/16 • From study enrollment through until study discontinuation
|
25.0%
1/4 • From study enrollment through until study discontinuation
|
16.7%
2/12 • From study enrollment through until study discontinuation
|
Additional Information
Krista Wahby, Critical Care Pharmacist in the Medical ICU
Harper University Hospital
Phone: 313-745-2711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place