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Study on the Effect of Dapagliflozin in Reducing Proteinuria in Patients with Chronic Kidney Disease After Kidney Transplant

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called dapagliflozin on patients who have received a kidney transplant and are experiencing chronic kidney disease. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste from the blood effectively. The medication being tested, dapagliflozin, is taken in the form of a 10 mg film-coated tablet known as Forxiga. The purpose of the study is to observe how this medication might help protect the kidneys, a concept known as nephroprotection, by reducing the amount of protein in the urine, which is a sign of kidney damage.

Participants in the study will take dapagliflozin and be monitored over a period of six months. The study will look at how well the medication works in reducing protein levels in the urine and whether it helps maintain kidney function. The study will also observe any changes in blood pressure, weight, and blood sugar levels, as well as any side effects that may occur, such as infections or changes in blood chemistry. The goal is to see if dapagliflozin can provide a protective effect on the kidneys in patients who have undergone a kidney transplant.

Throughout the study, researchers will also examine how dapagliflozin interacts with other medications that patients may be taking to suppress their immune system, which is necessary after a kidney transplant to prevent the body from rejecting the new organ. The study will help determine if dapagliflozin is a safe and effective option for protecting kidney function in these patients. Participants will be closely monitored for any adverse reactions or complications during the study period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Begin taking Forxiga 10 mg film-coated tablets. This medication contains dapagliflozin and is taken orally.

    Ensure that the initiation of dapagliflozin occurred less than 14 days ago for chronic kidney disease management.

  2. Step 2

    First three months

    Continue taking the prescribed dosage of Forxiga daily.

    Monitor for any changes in the albuminuria/creatinuria ratio. A decrease of 50% or more from the baseline or reaching a ratio of 30 mg/g or less is a key indicator.

    Observe any changes in kidney function, specifically a decrease of 50% or more in the glomerular filtration rate (GFR).

    Report any episodes of acute kidney issues, such as a significant increase in serum creatinine levels.

    Note any side effects, including infections or metabolic issues like dehydration or low blood sugar.

  3. Step 3

    Six months evaluation

    Continue the daily intake of Forxiga as prescribed.

    Evaluate the primary goal: a decrease in the albuminuria/creatinuria ratio by 50% or more from the baseline or achieving a ratio of 30 mg/g or less.

    Assess kidney function for any significant changes in GFR.

    Monitor for any severe kidney conditions requiring dialysis or transplant.

    Record any adverse reactions or side effects, including infections or metabolic disturbances.

    Review any changes in blood pressure, weight, and blood sugar levels.

  4. Step 4

    Ongoing monitoring

    Continue to take Forxiga as directed until the end of the study period.

    Regularly monitor kidney function and overall health.

    Report any new or worsening symptoms to the healthcare provider.

Who can join the trial?

6 criteria

  • You must have started taking **Dapagliflozin** for **chronic kidney disease** less than 14 days ago.
  • Your **eGFR** (a test that measures how well your kidneys are working) should be between 25 and 75 ml/min/1.73m².
  • Your **Albuminuria/Creatinuria ratio** (a test that checks for protein in your urine) should be between 200 mg/g and 5000 mg/g.
  • You should be on treatment with an **ACE inhibitor** or **angiotensin 2 receptor blocker** (also known as ARA II or sartan) at the highest dose you can handle for at least 4 weeks.
  • You must be 18 years old or older.
  • If you have had a **kidney transplant**, it should have been more than one year ago.

Who cannot join the trial?

1 criterion

  • Patients with chronic renal failure cannot participate. This means their kidneys are not working well over a long period.
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Investigated drugs

Dapagliflozin is a medication used in this clinical trial to help protect the kidneys in patients who have had a kidney transplant. It works by helping the kidneys remove excess sugar from the body through urine, which can also help reduce protein levels in the urine. This trial aims to see how effective Dapagliflozin is in providing kidney protection over a period of six months.

What is already known about the treatment

Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied for its potential nephroprotective effects in patients with chronic renal failure, particularly in the context of renal transplantation. The main therapeutic indication being explored is its ability to reduce proteinuria, which is a common issue in kidney transplant patients. At the molecular level, dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and promotes glucose excretion in the urine. It is classified as an SGLT2 inhibitor, a type of medication primarily used to manage blood sugar levels in individuals with type 2 diabetes.

Investigated diseases

Chronic Renal Failure – Chronic renal failure, also known as chronic kidney disease, is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This condition progresses over time, often without noticeable symptoms in the early stages. As kidney function declines, waste products and fluid can build up in the body, leading to symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of chronic renal failure can lead to complications like high blood pressure, anemia, and bone disease. In advanced stages, the kidneys may fail completely, requiring dialysis or a kidney transplant. The rate of progression can vary depending on the underlying cause and other health factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506295-26-00Protocol codeRECHMPL23_0102Estimated enrolment70 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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