EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743453
• Other study ID #: 41012620.6.1001.0068
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2022
• Source: University of Sao Paulo General Hospital
• Contact: Elias David-Neto, MD,PhD
• Phone: 55-11-2661-8089
• Email: pesquisaclinicautr.ichc[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 1, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Renal Transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the HCFMUSP and HRim;

2. =18years of age;

3. 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 Criteria:

1. Type 1 diabetes;

2. New York Heart Association Class IV congestive heart failure;

3. Myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment;

4. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment;

5. Any condition outside the renal and cardiovascular study area with a life expectancy of < 1 year based on investigator's clinical judgement;

6. 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;

7. Acute or chronic antibody mediated rejection;

8. Albuminuria due to other causes (mTOR inhibitors, Polyoma nephropathy, lymphoproliferative disorder etc…)

9. Patients with a previous medical history of recurrent urinary tract infections or severe genital infection;

10. Renal biopsies showing acute or chronic anti-body mediated rejection, transplant glomerulopathy, BKV nephropathy.

11. Patients under any other IS regimen besides Tacrolimus/MPA/Steroids

12. Pregnant patients as well as those breastfeeding.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Transplantation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - FMUSP	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the mean ?mGFR, between baseline and one year after randomization.	To evaluate the mean ?mGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (?mGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year).	12 months