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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04743453
Collaborator
Federal University of São Paulo (Other)
220
Enrollment
1
Location
2
Arms
23.5
Anticipated Duration (Months)
9.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study.
Actual Study Start Date :
Aug 17, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin

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 Comparator: Placebo

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the mean ΔmGFR, between baseline and one year after randomization. [12 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital das Clinicas - FMUSP Sao Paulo Brazil 05403900

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT04743453
Other Study ID Numbers:
  • 41012620.6.1001.0068
First Posted:
Feb 8, 2021
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of Sao Paulo General Hospital
Kidney Transplantation
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Dapagliflozin

Study Results

No Results Posted as of Feb 21, 2022