Kidney Transplant Recipients Clinical Trial
— HALLMARKOfficial title:
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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.). |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proximal tubular natriuresis with combination therapy | Measured by fractional excretion of sodium | From baseline to combination therapy end (24 weeks) | |
Primary | Proximal tubular natriuresis with monotherapy | Measured by fractional excretion of sodium | From baseline to monotherapy end (12 weeks) | |
Secondary | Measured Glomerular Filtration Rate | GFR, based on plasma iohexol clearance | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Estimated Glomerular Filtration Rate | GFR, based on serum creatinine | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Urinary 8-hydroxydeoxyguanosine and 8-isoprostane concentration | Using ELISA | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Urinary albumin excretion | From 24-hour urine collection | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Arterial stiffness | Measured using a Sphygmocor device | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Liver stiffness | Using transient elastography | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Diastolic function | Using 2D echocardiography | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Change in percentage of glycated hemoglobin (HbA1c) | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Change in concentration of urine glucose excretion | Urinary analysis will be performed to quantify the amount of glucose excretion. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Change in body composition (percent body mass, body fat, and muscle mass) | Bioimpedence measurements will be taken to study the effects of intervention on body composition. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | |
Secondary | Change in body weight | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: the incidence of acute kidney injury. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: the incidence of hypotension | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The incidence of hyperkalemia | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The incidence of urinary and mycotic infections. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The number of ketoacidosis events. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The incidence of amputations. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The incidence of pancreatitis or biliary complications | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] | ||
Secondary | Safety: The number of allergic reaction events. | From baseline to monotherapy end (12 weeks) and combination therapy end (24 weeks) ] |
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