| Trial ID: | L0806 |
| Source ID: | NCT04042324
|
| Associated Drug: |
Triferic
|
| Title: |
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04042324/results
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Triferic|DRUG: Heparin
|
| Outcome Measures: |
Primary: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t, 8 hours | Secondary: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours, 4 hours|aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours, 4 hours|TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours, 4 hours|Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration), 8 hours|Iron Profile as Measured by the AUC (Area Under the Curve) 0-t, 8 hours
|
| Sponsor/Collaborators: |
Sponsor: Rockwell Medical Technologies, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-30
|
| Completion Date: |
2020-01-16
|
| Results First Posted: |
2020-11-12
|
| Last Update Posted: |
2020-12-02
|
| Locations: |
Orlando Clinical Research Center, Orlando, Florida, 32809, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04042324
|
