Combination therapy of two diabetes medications in kidney transplant recipients
A Two Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of the Combined Use of Once Daily 10mg Dapagliflozin and Once Weekly 1.0mg Semaglutide in Kidney Transplant Recipients
This study is testing if a combination of two diabetes medications can help kidney transplant recipients improve their kidney function and heart health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05938712 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy, mechanisms, and safety of a combination therapy using dapagliflozin, an SGLT2 inhibitor, and semaglutide, a GLP-1 receptor agonist, in kidney transplant recipients. Over a 24-week period, participants will receive dapagliflozin and semaglutide separately for the first 12 weeks, followed by a combination of both medications for the next 12 weeks. The study aims to assess various health parameters, including kidney function, blood pressure, and overall safety of the treatment in this specific patient population. The research is particularly focused on understanding how these medications can protect kidney function and improve cardiovascular health in transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients aged 18 and older, at least three months post-transplant, with an eGFR of 20 ml/min/1.73m2 or higher.
Not a fit: Patients with type 1 diabetes, recent acute coronary events, or those with certain infections or medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could enhance kidney and heart protection in kidney transplant recipients, potentially improving their long-term health outcomes.
How similar studies have performed: While smaller studies have shown safety for SGLT2 inhibitors and GLP-1RA used alone in kidney transplant recipients, this combined approach has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Sunita Singh, MD MSc FRCPC — University Health Network, Toronto General Hospital
- Study coordinator: Vesta Lai
- Email: vesta.lai@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.