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

Primary Purpose

Kidney Transplantation, Diabetes Mellitus, Type 2, Diabetes Complications

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney Transplantation, Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clinicas - FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the mean ΔmGFR, between baseline and one year after randomization.
To evaluate the mean ΔmGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (ΔmGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year).

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
February 18, 2022
Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04743453
Brief Title
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS.
Official Title
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Diabetes Mellitus, Type 2, Diabetes Complications
Keywords
Kidney Transplantation, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the mean ΔmGFR, between baseline and one year after randomization.
Description
To evaluate the mean ΔmGFR, between baseline and one year after randomization between groups: Dapaglifozin and Placebo groups. (ΔmGFR is defind as the difference between measured GFR (mGFR) at baseline and at one year).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias David-Neto, MD,PhD
Phone
55-11-2661-8089
Email
pesquisaclinicautr.ichc@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Fabiana Agena, MS, PhD
Phone
55-11-2661-8089
Email
fabiana.agena@hc.fm.usp.br
Facility Information:
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias David-Neto, PhD
Phone
55-11-26618089
Email
pesquisaclinicautr.ichc@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Fabiana Agena, PhD
Phone
55-11-26618089
Email
fabiana.agena@hc.fm.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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

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