BridgeMD
Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease
EU CTIS ID: 2023-505890-34-00
What this study is testing
Exploring the safety of empagliflozin for kidney growth in ADPKD patients.
- 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
- Male and female patients ≥ 18 of age
- Screening eGFR ≥ 25 and ≤ 90 mL/min/1.73 m2 if age ≥ 18 and ≤50 years or Screening eGFR ≥ 25 and ≤ 65 mL/min/1.73 m2 if age > 50 years
- ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed)
- Mayo Class I C, D, E
- Patients with and without tolvaptan use will be included. Patients with tolvaptan use will be included if tolvaptan has been taken for ≥ 3 months at study entry.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
You likely can't join if
- Kidney or any other solid organ transplant recipient
- Women who are pregnant or breastfeeding
- Unwilling to practice acceptable methods of birth control during study participation
- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
- Currently receiving SGLT2-inhibitor
- Concomitant treatment with steroids or any other immunosuppressive agent
See the full eligibility criteria
- Male and female patients ≥ 18 of age
- Screening eGFR ≥ 25 and ≤ 90 mL/min/1.73 m2 if age ≥ 18 and ≤50 years or Screening eGFR ≥ 25 and ≤ 65 mL/min/1.73 m2 if age > 50 years
- ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed)
- Mayo Class I C, D, E
- Patients with and without tolvaptan use will be included. Patients with tolvaptan use will be included if tolvaptan has been taken for ≥ 3 months at study entry.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Evidence of signed written informed consent
- Kidney or any other solid organ transplant recipient
- Women who are pregnant or breastfeeding
- Unwilling to practice acceptable methods of birth control during study participation
- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
- Currently receiving SGLT2-inhibitor
- Concomitant treatment with steroids or any other immunosuppressive agent
- Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose)
- Ketoacidosis (laboratory based) in the past 5 years
- Type 1 diabetes mellitus
- Uncontrolled urinary tract- or genital infections
- Inability to fully understand the possible risks and benefits related to study participation
- Inability to undergo MRI exam (e.g. implanted medical devices)
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.