Chronic Renal Failure
Conditions
Keywords
Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure
Brief summary
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
Interventions
DRUGFragmin
variable dosing regimen
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* chronic renal failure on hemodialysis
Exclusion criteria
* significant comorbidities that would prevent a patient from completing the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent of Successful HD Sessions | 20 HD sessions (up to 4 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent of HD Sessions With an Acceptable Dose | 20 HD sessions (up to 4 hours) | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Does not meet entrance criteria | 1 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Surgery;changed schedule; not available | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | FRAGMIN |
|---|---|
| Age, Continuous | 57.1 Years STANDARD_DEVIATION 14.7 |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 152 |
| serious Total, serious adverse events | 3 / 152 |
Outcome results
Primary
Mean Percent of Successful HD Sessions
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FRAGMIN | Mean Percent of Successful HD Sessions | 99.9 Percentage of HD Sessions |
Secondary
Mean Percent of HD Sessions With an Acceptable Dose
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FRAGMIN | Mean Percent of HD Sessions With an Acceptable Dose | 89.8 Percentage of HD sessions |