Trials / Completed
CompletedNCT04743453
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Sodium-glucose co-transporter 2 (SGLT2) inhibitors reduce plasma glucose and haemoglobin A1c(HbA1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion. However, in some situations lead to a diminished number of functional glomeruli with a consequent hyperfiltration in the remaining ones. This fact may be where the use of SGLT2 inhibitor could attenuate the renal damage. The purpose of our study is to evaluate the impact of using dapagliflozin on the renal functional deterioration of renal transplanted patients diabetics or not. This is a prospective, randomized, single-blinded, double-center, controlled trial. Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin | Dapagliflozin 10 mg: Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose. |
| DRUG | Placebo | Placebo will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose. |
Timeline
- Start date
- 2021-08-17
- Primary completion
- 2024-09-02
- Completion
- 2024-09-02
- First posted
- 2021-02-08
- Last updated
- 2024-09-05
Locations
1 site across 1 country: Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04743453. Inclusion in this directory is not an endorsement.