Status:
COMPLETED
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Federal University of São Paulo
Conditions:
Kidney Transplantation
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-d...
Eligibility Criteria
Inclusion
- Renal Transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the HCFMUSP and HRim;
- ≥18years of age;
- 45 ≥ eGFR ≥ 25 mL/min/1.73m2 or 45\<eGFR\<60 ml/min/1.73m2 with a loss of eGFR of ≥10% in the last year.
Exclusion
- Type 1 diabetes;
- New York Heart Association Class IV congestive heart failure;
- Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment;
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment;
- Any condition outside the renal and cardiovascular study area with a life expectancy of \< 1 year based on investigator's clinical judgement;
- Hepatic impairment \[aspartate transaminase or alanine transaminase \>3 times the upper limit of normal (ULN) or total bilirubin \>2 times the ULN at the time of enrolment;
- Acute or chronic antibody mediated rejection;
- Albuminuria due to other causes (mTOR inhibitors, Polyoma nephropathy, lymphoproliferative disorder etc…)
- Patients with a previous medical history of recurrent urinary tract infections or severe genital infection;
- Renal biopsies showing acute or chronic anti-body mediated rejection, transplant glomerulopathy, BKV nephropathy.
- Patients under any other IS regimen besides Tacrolimus/MPA/Steroids
- Pregnant patients as well as those breastfeeding.
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2024
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT04743453
Start Date
August 17 2021
End Date
September 2 2024
Last Update
September 5 2024
Active Locations (1)
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1
Hospital das Clinicas - FMUSP
São Paulo, Brazil, 05403900