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Study of Dapagliflozin to Preserve Function in Transplanted Kidneys

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients who have received a kidney transplant. The research examines whether a medication called dapagliflozin can help protect and maintain the health of transplanted kidneys over time. Dapagliflozin belongs to a group of medications known as SGLT2 inhibitors, which are typically used to manage blood sugar levels.

The study compares dapagliflozin with a placebo to determine if the medication can slow down the natural decline in kidney function that may occur after transplantation. The medication is taken as a film-coated tablet by mouth. The study will track how well the transplanted kidney functions over a period of three years.

During the study, participants will receive either dapagliflozin (10 mg daily) or a placebo. The kidney function will be monitored through regular blood tests that measure how well the kidney filters waste products from the blood. The study will also look at other aspects of health, including blood pressure, body composition, and the overall safety of the treatment in transplant recipients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your participation begins 6 weeks (plus/minus 2 weeks) after receiving a kidney transplant at the hospital.
A medical evaluation will confirm if your estimated kidney function (eGFR) is at least 25 mL/min/1.73 m2.
Your current medications will be reviewed to ensure proper dosage of transplant medicines.
Step 2
Treatment assignment
You will be randomly assigned to receive either dapagliflozin or a placebo (inactive pill).
The medication is taken by mouth.
You will continue taking your regular transplant medications as prescribed by your doctor.
Step 3
Regular monitoring - first 72 weeks
Your kidney function will be checked at least four times per year through blood tests.
Urine samples will be collected at least four times per year.
Blood pressure measurements will be taken regularly.
A special kidney function test using iohexol will be performed at week 2 and week 72.
A body composition scan (DXA) will be done at week 2 and week 72.
A glucose tolerance test will be performed at the start and at week 72.
A small sample of kidney tissue (biopsy) will be taken at the start and at week 72.
Step 4
Extended monitoring - up to 150 weeks
Blood tests will continue at least four times per year to check kidney function.
Urine samples will continue to be collected at least four times per year.
Blood pressure monitoring will continue.
Any health issues will be recorded and monitored.
Step 5
Long-term follow-up
Annual kidney function checks will continue for up to 10 years.
Your health records will be monitored for any heart or blood vessel related events.
The study will end in December 2028.

Who can join the trial?

6 criteria

Must have received a kidney transplant approximately 6 weeks (plus or minus 2 weeks) ago
Must be between 18 and 75 years of age
Must be able to manage and take medications independently
Must have stable levels of anti-rejection medications (including calcineurin inhibitors, prednisolone, and mycophenolate mofetil) within the recommended range for at least 2 weeks
Must have adequate kidney function with an estimated GFR (a measure of how well kidneys filter blood) of at least 25 mL/min/1.73 m2
Can be either male or female

Who cannot join the trial?

15 criteria

Age below 18 years or above 85 years
Known allergy or hypersensitivity to dapagliflozin (the study medication)
Current pregnancy or breastfeeding
Previous organ transplant rejection
Type 1 diabetes (an autoimmune condition where the body doesn't produce insulin)
Active urinary tract infection
Severe liver disease
Participation in another clinical trial within the past 30 days
eGFR (estimated kidney function rate) less than 25 mL/min/1.73m²
History of ketoacidosis (a serious complication where the blood becomes too acidic)
Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >100 mmHg)
Recent major surgery (within 8 weeks)
History of kidney transplant failure
Active cancer or cancer treatment
Severe heart disease or recent heart attack

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Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

Dapagliflozin is a medication that belongs to a group called SGLT2 inhibitors. It works by helping the kidneys remove excess sugar from the blood through urine. In transplant patients, this medication is being studied to see if it can help protect and preserve the function of the transplanted kidney. It may help slow down the natural decline in kidney function that can occur after transplantation.

Dapagliflozin

What is already known about the treatment

Dapagliflozin - An oral medication belonging to the class of SGLT2 inhibitors (sodium-glucose cotransporter-2 inhibitors) that works by reducing blood sugar levels through increased glucose excretion in urine. The drug is currently being investigated for its potential benefits in kidney transplant patients, as it may help preserve kidney function and slow down the decline in kidney filtering ability (GFR). In addition to its established use in type 2 diabetes treatment, dapagliflozin shows promise in protecting kidney health by reducing stress on the filtering units of the kidney and improving overall kidney blood flow, making it a subject of interest in transplant medicine.

Investigated diseases

Kidney Transplantation - A medical condition where a healthy kidney from a donor is surgically placed into a recipient's body to replace their damaged or failing kidney. After transplantation, the body needs time to accept the new organ, and the immune system must adapt to its presence. The transplanted kidney takes over the functions of filtering waste products from the blood, regulating blood pressure, and maintaining proper fluid balance in the body. The recipient's body gradually adjusts to the new kidney through a process called adaptation, during which the organ begins to function normally. The success of the transplant depends on various biological factors and how well the recipient's body accepts the new organ.