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

NCT04743453 | Completed Phase 4 FDA Drug

• 1 other identifier: 41012620.6.1001.0068
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Diabetes Mellitus, Type 2; Diabetes Complications

Keywords

Kidney Transplantation; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dapagliflozin DRUG

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.

Dapagliflozin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Hospital das Clinicas - FMUSP

São Paulo, 05403900, Brazil

Location

Related Publications (1)

• Gill M, Leung M, Luo CY, Cheung C, Beauchesne A, Chang D, Lan J, Johnston O. Erythrocytosis and thrombotic events in kidney transplant recipients prescribed a sodium glucose cotransport-2 inhibitor. Clin Transplant. 2023 Aug;37(8):e15013. doi: 10.1111/ctr.15013. Epub 2023 May 11.

  PMID: 37170711 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to add either Dapagliflozin 10 mg or Placebo to their treatment. Study drug will be administered by once-daily orallly.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: August 17, 2021
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: September 5, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)