| Trial ID: | L7326 |
| Source ID: | NCT04743453
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation|Diabetes Mellitus, Type 2|Diabetes Complications
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Evaluate the mean ΔmGFR, between baseline and one year after randomization., To evaluate the mean ΔmGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (ΔmGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year)., 12 months |
|
| Sponsor/Collaborators: |
Sponsor: University of Sao Paulo General Hospital | Collaborators: Federal University of São Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
211
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-08-17
|
| Completion Date: |
2024-09-02
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-05
|
| Locations: |
Hospital das Clinicas - FMUSP, Sao Paulo, 05403900, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT04743453
|
