Trial Outcomes & Findings for Use Of Fragmin In Hemodialysis (NCT NCT01879618)
NCT ID: NCT01879618
Last Updated: 2017-03-10
Results Overview
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
COMPLETED
PHASE3
152 participants
20 HD sessions (up to 4 hours)
2017-03-10
Participant Flow
The study was conducted in 12 sites in Canada, 10 of which enrolled participants. A total of 152 participants with chronic renal failure, who had at least 30 previous days of hemodialysis (HD) and had received ≤10,000 IU unfractionated heparin or low molectular weight heparin for anticoagulation during the past month were enrolled in the study.
The Screening Visit was performed within 9 days preceding first HD session where FRAGMIN was administered. The Final Study Visit took place 5 to 15 days after the final study HD session where the participant was treated with Fragmin (# 20 or the last HD session that was completed, if the partcipant prematurely terminated).
Participant milestones
| Measure |
FRAGMIN
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
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Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
FRAGMIN
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
|
Overall Study
Does not meet entrance criteria
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Surgery;changed schedule; not available
|
8
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Adverse Event
|
5
|
Baseline Characteristics
Use Of Fragmin In Hemodialysis
Baseline characteristics by cohort
| Measure |
FRAGMIN
n=152 Participants
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
|
Age, Continuous
|
57.1 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 HD sessions (up to 4 hours)Population: The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
Outcome measures
| Measure |
FRAGMIN
n=151 Participants
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
|
Mean Percent of Successful HD Sessions
|
99.9 Percentage of HD Sessions
Interval 99.7 to 100.0
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SECONDARY outcome
Timeframe: 20 HD sessions (up to 4 hours)Population: FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.
A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time \> 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.
Outcome measures
| Measure |
FRAGMIN
n=148 Participants
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
|
Mean Percent of HD Sessions With an Acceptable Dose
|
89.8 Percentage of HD sessions
Interval 87.4 to 91.9
|
Adverse Events
FRAGMIN
Serious adverse events
| Measure |
FRAGMIN
n=152 participants at risk
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
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Infections and infestations
Influenza
|
0.66%
1/152 • Number of events 1 • From screening (-9 days) up to 30 days after last dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/152 • Number of events 1 • From screening (-9 days) up to 30 days after last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1 • From screening (-9 days) up to 30 days after last dose of study drug.
|
Other adverse events
| Measure |
FRAGMIN
n=152 participants at risk
Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
|
|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
12.5%
19/152 • Number of events 19 • From screening (-9 days) up to 30 days after last dose of study drug.
|
|
Vascular disorders
Hypotension
|
5.3%
8/152 • Number of events 8 • From screening (-9 days) up to 30 days after last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER