Ended Therapeutic use (Phase IV) chronic renal failure

Evolution of proteinuria in renal transplant patients treated with Dapagliflozin

EU CTIS ID: 2023-506295-26-00

What this study is testing

Estimate the rate of patients, treated with Dapagliflozin, with a nephroprotective effect at 6 months after dapagliflozin initiation

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Initiation of dapagliflozin less than 14 days ago for chronic kidney disease
  • eGFR (by CKD-EPI) between 25 and 75 ml.min.1.73m²
  • Albuminuria/Creatinuria ratio between 200 mg/g and 5000 mg/g
  • Treatment with an ACE inhibitor or angiotensin 2 receptor blocker (ARA II or sartan) at the maximum tolerated dose for at least 4 weeks
  • Age ≥ 18 years
  • For CKD Renal Transplant Recipients: kidney transplant more than one year

You likely can't join if

  • Guardianship or trusteeship
  • Patient undergoing treatment with another SGLT2 inhibitor (sodium-glucose co-transporter type 2)
  • Patient enrolled in another clinical trial
  • Pregnancy or breast-feeding
  • Patient protected by law
  • Subject not affiliated to a social security scheme, or not benefiting from such a scheme
See the full eligibility criteria
Who can join
  • Initiation of dapagliflozin less than 14 days ago for chronic kidney disease
  • eGFR (by CKD-EPI) between 25 and 75 ml.min.1.73m²
  • Albuminuria/Creatinuria ratio between 200 mg/g and 5000 mg/g
  • Treatment with an ACE inhibitor or angiotensin 2 receptor blocker (ARA II or sartan) at the maximum tolerated dose for at least 4 weeks
  • Age ≥ 18 years
  • For CKD Renal Transplant Recipients: kidney transplant more than one year
What rules you out
  • Guardianship or trusteeship
  • Patient undergoing treatment with another SGLT2 inhibitor (sodium-glucose co-transporter type 2)
  • Patient enrolled in another clinical trial
  • Pregnancy or breast-feeding
  • Patient protected by law
  • Subject not affiliated to a social security scheme, or not benefiting from such a scheme
  • Patient deprived of liberty
  • For the control group (non-transplanted CKD) : history of transplantation
  • Initiation or modification of immunosuppressive therapy less than 6 months ago (except temporary discontinuation for infection or change in dosage)
  • Type 1 diabetes
  • Severe liver failure (Child-Pugh stage C)
  • Intolerance to any of the excipients of Forxiga®, in particular lactose intolerance

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.