Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?

Launched by OSLO UNIVERSITY HOSPITAL · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dapagliflozin on kidney transplant recipients. Specifically, it aims to see if this medication can help protect the kidney from damage and improve overall health after a transplant. Researchers will look at whether dapagliflozin can maintain kidney function, reduce kidney scarring, and improve health factors that could lead to kidney failure, like weight gain, high blood sugar, and high blood pressure. The study will involve 330 participants who received a kidney transplant six weeks earlier. They will either take dapagliflozin or a placebo (a look-alike pill with no active medication) for three years.

To participate, you need to be between 18 and 75 years old, have received a kidney transplant at Oslo University Hospital, and have certain kidney function levels. If you are eligible and choose to participate, you will have regular check-ups, including tests to assess kidney function and other health markers. It's important to know that there are some exclusions, such as having had a repeat transplant or certain other health conditions. This trial could provide valuable information to help improve the care of kidney transplant patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet.
• • Age 18-75 years.
• • Able to comply with the medical treatment on their own.
• • Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.
• • Estimated GFR ≥25 mL/min/1.73 m2.
• Exclusion Criteria:
• • Type 1 diabetes
• • Rejection episodes of the kidney graft prior to randomization.
• • Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele.
• • Malnutrition.
• • Urosepsis less than 1 year prior to randomization.
• • Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
• • For women only - currently pregnant