Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)

Korábbi kezelés

• Kidney or any other solid organ transplant recipient
• Currently receiving SGLT2-inhibitor
• Concomitant treatment with steroids or any other immunosuppressive agent
• Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)

Más betegség

• Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose)
• Type 1 diabetes mellitus
• Ongoing urinary tract- or genital infections

Laborértékek

• Ketoacidosis (laboratory based) in the past 5 years

Egyéb

• Inability to fully understand the possible risks and benefits related to study participation
• Inability to undergo MRI exam (e.g. implanted medical devices)
• Women who are pregnant or breastfeeding
• Unwilling to practice acceptable methods of birth control during study participation

• 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.