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The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients

ConditionKidney Transplant Recipients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

The study aims to determine the short-term efficacy, mechanisms and safety of 12 weeks of dapagliflozin and semaglutide combination therapy in 20 KTR, with and without T2D.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated written informed consent.

Patients aged ≥18 years with KTR

>3 months post kidney transplantation

Estimated glomerular filtration rate [eGFR] ≥20 ml/min/1.73m2

Disqualifiers

Type 1 diabetes.

History of multi-organ transplant

Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening

Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening

Trial design

Design model

Sequential

Treatments tested in this trial

  • Dapagliflozin 10 MG

    Drug

    Semaglutide subcutaneous once weekly for 12 weeks.

  • Semaglutide, 1.0 mg/mL

    Drug

    Dapagliflozin oral once daily for 12 weeks.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 2 interventions
Group B: DapagliflozinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proximal tubular natriuresis with combination therapy

Measured by fractional excretion of sodium

Time frame
From baseline to combination therapy end (24 weeks)
2

Proximal tubular natriuresis with monotherapy

Measured by fractional excretion of sodium

Time frame
From baseline to monotherapy end (12 weeks)

Secondary outcomes

1

Measured Glomerular Filtration Rate

GFR, based on plasma iohexol clearance

Time frame
From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
2

Estimated Glomerular Filtration Rate

GFR, based on serum creatinine

Time frame
From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
3

Urinary 8-hydroxydeoxyguanosine and 8-isoprostane concentration

Using ELISA

Time frame
From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]
4

Urinary albumin excretion

From 24-hour urine collection

Time frame
From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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