Effects of Jardiance on Kidney Transplant Oxygen Levels
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension: A Randomized, Double-blind, Placebo Controlled Crossover Trial
This study is testing if a single dose of Jardiance can improve oxygen levels in kidney transplants for people who don’t have diabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Odense C) |
| Trial ID | NCT06933355 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a single dose of Jardiance (50 mg) on oxygen tension in kidney transplants among non-diabetic recipients. It employs a randomized, double-blind, placebo-controlled, crossover design, where participants will receive both the medication and a placebo in separate sessions. The study aims to measure changes in kidney oxygenation and blood flow using blood-oxygen-dependent level magnetic resonance imaging (BOLD-MRI). The primary endpoint focuses on assessing cortical and medullary oxygen tension, while secondary endpoints include perfusion and blood flow metrics.
Who should consider this trial
Good fit: Ideal candidates are non-diabetic kidney transplant recipients who are at least 6 months post-transplant and have stable kidney function.
Not a fit: Patients with diabetes or those experiencing renal allograft failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance kidney transplant outcomes by improving oxygenation and function of the transplanted organ.
How similar studies have performed: While the use of SGLT2 inhibitors in non-transplant patients has shown promise, this specific application in kidney transplant recipients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients, age ≥ 18 years. * Non-diabetic kidney transplant recipients * \> 6 months post-transplant * Stable eGFR\> 20 ml/min (defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months) * Immunosuppressive: Tacrolimus (Adport) and Mycophenolatmofetil (Myfenax/Cellcept/Mycophenolatmofetil) * Capable of lying in a MR-scanner * Capable of providing a signed informed consent and comply with study requirements. * Negativ pregnancy test Exclusion Criteria: * Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria) * Hemoglobin A1c ≥ 48 mmol/mol * Fasting venous plasma glucose ≥ 7,0 mmol/l or * 2-hours venous plasma glucose ≥ 11,1 mmol/l after oral glucose tolerance test (OGTT). * Renal allograft failure (eGFR\< 20 ml/min) * Alanine aminotransferase (ALAT) \> 3 x upper normal limit * Bilirubin \> 2 x upper normal limit * Prednisone treatment * Pregnancy * Breastfeeding * Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-s
Where this trial is running
Odense C
- Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor — Odense C, Denmark (Recruiting)
Study contacts
- Principal investigator: Lotte B Lange, MD — Department of Nephrology, Odense University Hospital
- Study coordinator: Lotte B Lange, MD
- Email: lotte.borg.lange@rsyd.dk
- Phone: +45 40863392
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.