Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01879618 | Use Of Fragmin In Hemodialysis | PHASE3 | COMPLETED | 152 | — | — | Oct 1, 2013 | Mar 1, 2016 | Mar 10, 2017 | 19 | Canada |
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.
| Arm | Type | Description |
|---|---|---|
| Fragmin | EXPERIMENTAL | Fragmin given according to the flexible dosing regimen outlined in the protocol |
| Name | Type | Description |
|---|---|---|
| Fragmin | DRUG | variable dosing regimen |
Inclusion Criteria: * chronic renal failure on hemodialysis Exclusion Criteria: * significant comorbidities that would prevent a patient from completing the trial