Type 2 Diabetes Clinical Trial
— INFINITI2019Official title:
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients: The INFINITI Study
This study will be a randomized, double-blind, placebo-controlled clinical trial comparing the SGLT2 inhibitor dapagliflozin to placebo in 52 kidney transplant recipients (KTR) with or without pre-existing type 2 diabetes (T2D) or post-transplant diabetes mellitus (PTDM). The primary outcome of the trial is to determine if dapagliflozin is superior to placebo in reduction of blood pressure in KTR.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | June 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Male or females >18 years old = 6months after kidney transplantation; 2. In patients with T2D or PTDM, HbA1c <12.0%; 3. eGFR =30 ml/min/1.73m^2 (as per the CKD-EPI equation); 4. BMI =45kg/m^2; 5. Blood pressure =160/90 and =90/60 at screening. Exclusion Criteria: 1. Diagnosis of type 1 diabetes; 2. Presence of severe peripheral vascular disease (i.e. prior amputation, gangrene, non-healing ulcer or ischemic rest pain); 3. Presence of acute coronary syndrome, stroke or transient ischemic attack in the 3 months prior to screening; 4. Prior episode of graft pyelonephritis in the 1 month prior to screening; 5. Episode of acute graft rejection in the 3 months prior to screening; 6. Initiation of a new immunosuppressive agent or discontinuation of an immunosuppressive agent in the 1 month prior to screening; 7. Untreated urinary or genital tract infection; 8. Severe hypoglycemia within 3 months of screening, or hypoglycemia unawareness; 9. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control; 10. Participation in another trial with an investigational drug within 30 days of informed consent; 11. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation; 12. Any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement. 13. Patients currently using antipsychotic medications. 14. Use of SGLT2 inhibitors within 1 month of starting the study. |
Country | Name | City | State |
---|---|---|---|
Canada | Renal Physiology Laboratory | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic blood pressure | SBP | Change from baseline systolic blood pressure (SBP) at 12 weeks of treatment | |
Secondary | Fasting plasma glucose | Fasting plasma glucose | Change from baseline fasting plasma glucose at 12 weeks of treatment | |
Secondary | HbA1c | HbA1c | Change from baseline HbA1c at 12 weeks of treatment | |
Secondary | Continuous home glucose monitoring | Continuous home glucose monitoring | Continuous glucose will be monitored for 14 days at 2 time intervals: 7 days prior to 7 days after drug administration (week -1 to1) and 7 days prior to 7 days after during drug discontinuation (week 11 to 13) | |
Secondary | Arterial stiffness | Measured using a Sphygmocor device | Change from baseline arterial stiffness at 12 weeks of treatment | |
Secondary | Systemic vascular resistance | Measured using non-invasive cardiac output monitor (NICOM) | Change from baseline systemic vascular resistance at 12 weeks of treatment | |
Secondary | Glomerular Filtration Rate | GFR | Change from baseline GFR (based on plasma iohexol clearance) at 12 weeks of treatment | |
Secondary | Estimated Glomerular Filtration Rate | eGFR | Change from baseline eGFR (based on CKD-EPI equation) at 12 weeks of treatment | |
Secondary | Proximal tubular natriuresis | Measured by fractional excretion of sodium and 24-hour urine collection | Change from baseline proximal tubular natriuresis at 12 weeks of treatment | |
Secondary | Albuminuria | Albuminuria | Change from baseline albuminuria at 12 weeks of treatment | |
Secondary | Urinary and plasma concentration of oxidative stress markers | Measured using ELISA | Change from baseline oxidative stress markers at 12 weeks of treatment | |
Secondary | Tubulointerstitial hypoxia | Measured using a renal ultrasound (photoacoustic ultrasonography) | Change from baseline tubulointerstitial hypoxia at 12 weeks of treatment | |
Secondary | Calcineurin inhibitor (CNI) Levels | CNI | Change from baseline CNI at 12 weeks of treatment | |
Secondary | Adverse Events (AEs) | AEs | Adverse events will be recorded from baseline throughout the study duration up to 13 weeks |
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