| Trial ID: | L0771 |
| Source ID: | NCT05343078
|
| Associated Drug: |
Dapagliflozin 10mg Tab
|
| Title: |
Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients
|
| Acronym: |
DARE-ESKD 1
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-stage Renal Disease
|
| Interventions: |
DRUG: Dapagliflozin 10Mg Tab
|
| Outcome Measures: |
Primary: Area under the curve of the plasma concentration-time curve of dapagliflozin, AUC of dapagliflozin (ng.mL / mL), From dialysis initiation to 48 hours post- drug administration | Secondary: Area under the curve of the plasma concentration-time curve of D3OG, AUC of D3OG (ng.mL / mL), From dialysis initiation to 48 hours post- drug administration|Steady-state plasma concentration of Dapagliflozin, Steady-state plasma concentration (ng/mL), 7 days|Steady-state accumulation ratio of Dapagliflozin, Accumulation index, 7 days|Total mass of dapagliflozin extracted by the dialysis, Dapagliflozin mass (mg), 7 days
|
| Sponsor/Collaborators: |
Sponsor: University of Campinas, Brazil
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-04-25
|
| Completion Date: |
2022-10-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-09
|
| Locations: |
University of Campinas, Campinas, SP, 13083-887, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT05343078
|
