Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743453
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2021-02-02
Brief Title:
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS A Prospective Randomized Single-blinded Placebo- Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sodium-glucose co-transporter 2 SGLT2 inhibitors reduce plasma glucose and haemoglobin A1cHbA1c 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None