Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease
Key facts
- Where
- Hanover, NémetországSee the site
- Phase
- 4. fázis
Where in Németország
- Medizinische Hochschule HannoverHanover, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medizinische Hochschule Hannover
- Trial code
- EU 2023-505890-34-00
- Record updated
- 2025. szeptember 30.
- Original description
Exploring the safety of empagliflozin for kidney growth in ADPKD patients.Read full original descriptionShow less
Exploring the safety of empagliflozin for kidney growth in ADPKD patients.
Inclusion: 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.
Exclusion: Kidney or any other solid organ transplant recipient; 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); Type 1 diabetes mellitus; Uncontrolled urinary tract- or genital infections; Ketoacidosis (laboratory based) in the past 5 years; Women who are pregnant or breastfeeding; Unwilling to practice acceptable methods of birth control during study participation; Inability to fully understand the possible risks and benefits related to study participation; Inability to undergo MRI exam (e.g. implanted medical devices).