Clinical Trial Details
| Trial ID: | L0795 |
| Source ID: | NCT04409132 |
| Associated Drug: | Triferic |
| Title: | Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus. |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | End Stage Renal Disease |
| Interventions: | DRUG: Triferic |
| Outcome Measures: | Primary: Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D, 8 hours|Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D, 8 hours | Secondary: Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D, 8 hours|Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D, 8 hours|Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D, 8 hours|Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D, 8 hours |
| Sponsor/Collaborators: | Sponsor: Rockwell Medical Technologies, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1|PHASE2 |
| Enrollment: | 23 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2020-06-25 |
| Completion Date: | 2021-04-02 |
| Results First Posted: | |
| Last Update Posted: | 2021-07-13 |
| Locations: | Orlando Clinical Research Center, Orlando, Florida, 32809, United States |
| URL: | https://clinicaltrials.gov/show/NCT04409132 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|