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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination therapy using two medications, dapagliflozin and semaglutide, in kidney transplant recipients. The goal is to see how well this treatment works, how it works in the body, and whether it is safe for patients over a 12-week period. The study is specifically looking at patients who have received a kidney transplant, regardless of whether they have diabetes or not.

To participate in this trial, patients must be at least 18 years old and have had their kidney transplant for more than three months. They should have a certain level of kidney function and meet other health criteria. During the trial, participants will take the two medications and be monitored for any side effects and how their bodies respond. It's important for potential participants to be aware that some people, such as those with certain medical histories or conditions, may not be eligible to join the study. Overall, this trial aims to help improve treatment options for kidney transplant recipients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • BP \<160/100 and \>90/60 at screening
• • Body-mass index \[BMI\] between 18.5-40kg/m2
• • In patients with T2D or PTDM, HbA1c \<12.0%;
• Exclusion Criteria:
• • 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
• • Actively treated BK, CMV or EBV infection
• • Recurrent pyelonephritis or need for indwelling or self-catheterization
• • Prior amputation or ischemic rest pain
• • Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
• • History of pancreatitis
• • Personal or family history or medullary thyroid cancer or MEN2B
• • History of unstable diabetic retinopathy within 1 year prior to screening
• • Use of SGLT2i or GLP-1RA within 30 days prior to screening.
• • Current and frequent episodes of hypoglycemia
• • Current history of DKA requiring medical intervention or hospitalization
• • With current risk of volume depletion, hypotension and/or electrolyte imbalance
• • With known or suspected hypersensitivity to semaglutide or related products
• • Patient not able to understand and comply with study requirements, based on Investigator's judgment.
• • Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome etc.).