The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Pep… (NCT05938712) | Clinical Trial Compass
RecruitingPhase 2
The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
Canada20 participantsStarted 2023-10-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conditi…
What they're measuring
1
Proximal tubular natriuresis with combination therapy
Timeframe: From baseline to combination therapy end (24 weeks)
2
Proximal tubular natriuresis with monotherapy
Timeframe: From baseline to monotherapy end (12 weeks)