A Phase 3 interventional study of Fragmin in Chronic Renal Failure, sponsored by Pfizer. Completed at 19 sites in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 152 is above the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fragmin given according to the flexible dosing regimen outlined in the protocol
Drug: Fragmin
variable dosing regimen
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)
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)
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.
| Milestone | FRAGMIN |
|---|---|
| Started | 152 |
| Completed | 131 |
| Not completed | 21 |
| Withdrew: Does not meet entrance criteria | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Surgery;changed schedule; not available | 8 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Adverse event | 5 |
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.
| Percentage of HD Sessions | FRAGMIN |
|---|---|
| Mean Percent of Successful HD Sessions | 99.9 (99.7 to 100) |
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.
| Percentage of HD sessions | FRAGMIN |
|---|---|
| Mean Percent of HD Sessions With an Acceptable Dose | 89.8 (87.4 to 91.9) |
Collected over From screening (-9 days) up to 30 days after last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FRAGMIN | — | 3/152 (2%) | 27/152 (17.8%) |
| Event | FRAGMIN |
|---|---|
| Atrial fibrillationCardiac disorders | 1/152 |
| PneumoniaInfections and infestations | 1/152 |
| InfluenzaInfections and infestations | 1/152 |
| Event | FRAGMIN |
|---|---|
| Arteriovenous fistula site haemorrhageInjury, poisoning and procedural complications | 19/152 |
| HypotensionVascular disorders | 8/152 |
The Safety Analysis Set consisted of all participants who received at least one dose of study medication.
| Age, Continuous(Years) | FRAGMIN |
|---|---|
| Mean | 57.1 ± 14.7 |
| Sex: Female, Male(Participants) | FRAGMIN |
|---|---|
| Female | 46 |
| Male | 106 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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