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

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Dapagliflozin (experimental).

The registry classes the interventions as drug.

More on the Plan

However, treatment options to protect the heart and the kidney in transplant recipients are lacking.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) are novel anti-diabetic drugs which not only lower blood sugar, but also lower blood pressure in the kidney's individual filtering units and protect kidney function in the long term.

It is unclear if the protective mechanisms of these drugs also occur in people with a kidney transplant.

No studies have yet to look at the combined use of SGLT2 inhibitors and GLP-1RA in kidney transplant recipients (KTR).

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed and dated written informed consent. Patients aged ≥18 years with KTR. \>3 months post kidney transplantation. BP \<160/100 and \>90/60 at screening. Body-mass index \[BMI\] between 18.5-40kg/m2.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes; history of multi-organ transplant; acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening.

How the Study Was Run

The set-up was randomized, sequential and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-10-24 with completion listed for 2027-10-01.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proximal tubular natriuresis with combination therapy (time frame: From baseline to combination therapy end (24 weeks)). Proximal tubular natriuresis with monotherapy (time frame: From baseline to monotherapy end (12 weeks)).

It also tracked 19 secondary outcomes, for example Measured Glomerular Filtration Rate, Estimated Glomerular Filtration Rate, Urinary 8-hydroxydeoxyguanosine and 8-isoprostane concentration, Urinary albumin excretion, Arterial stiffness and Liver stiffness.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.