NCT04743453CompletedPhase 4

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.

Source: ClinicalTrials.gov · Last updated 5 Sept 2024

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 211 (actual)
First submitted: 2 Feb 2021
Start date: 17 Aug 2021
Primary completion date: 2 Sept 2024
Lead sponsor: University of Sao Paulo General Hospital
Diseases: Type 2 diabetes
NCT number: NCT04743453

What you commit to

Study type: Interventional · Phase 4
Participants enrolled: 211
From 17 Aug 2021 to the primary completion date, 2 Sept 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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;
Acute or chronic antibody mediated rejection;
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

Other illness

Type 1 diabetes;
New York Heart Association Class IV congestive heart failure;
Any condition outside the renal and cardiovascular study area with a life expectancy of \< 1 year based on investigator's clinical judgement;
Albuminuria due to other causes (mTOR inhibitors, Polyoma nephropathy, lymphoproliferative disorder etc…)

Lab values

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;

Other

Pregnant patients as well as those breastfeeding.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status	São Paulo	Brazil	Unknown status

Related publications

The Effect of Adding Dapagliflozin on Chronic Renal Allograft Dysfunction: A Randomized, Prospective, Double-blind, Placebo-controlled Trial.Transplantation · 2026 · PMID 42102257

This page is information, not medical advice. Discuss any trial with your doctor.