Authorised Therapeutic exploratory (Phase II) Chronic Kidney Disease

SGLT2 lnhibition in Hemodialysis (DAPA-HD)

EU CTIS ID: 2024-518591-31-00

What this study is testing

Comparing Cardiovascular Outcome between SGLT2i and Placebo

  • Therapeutic exploratory (Phase II)

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

  • • Age ≥18 years
  • • Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
  • • BMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months
  • • Signed informed consent

You likely can't join if

  • o Hypersensitivity or Intolerance of SGLT2 inhibitors
  • o Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.
  • o Acute coronary syndrome during the last 30 days
  • o SGLT2i within the last 6 months
  • o Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
  • o Pregnancy
See the full eligibility criteria
Who can join
  • • Age ≥18 years
  • • Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
  • • BMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months
  • • Signed informed consent
What rules you out
  • o Hypersensitivity or Intolerance of SGLT2 inhibitors
  • o Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.
  • o Acute coronary syndrome during the last 30 days
  • o SGLT2i within the last 6 months
  • o Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
  • o Pregnancy
  • o Breast feeding
  • o Participation in another clinical trial
  • o History of diabetic ketoacidosis
  • o Life expectancy < 1 year
  • o Interventricular septum width ≤ 11 mm
  • o Severe valvular heart disease
  • o Substance abuse
  • o History of Type 1 diabetes mellitus
  • o Scheduled kidney transplant from a living donor

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.