Empagliflozin for Autosomal dominant polycystic kidney disease

Inclusion criteria

• {"criterion_text":"- Male and female patients ≥ 18 of age\n- 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\n- ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed)\n- Mayo Class I C, D, E\n- 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.\n- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n- Evidence of signed written informed consent"}

Exclusion criteria

• {"criterion_text":"- Kidney or any other solid organ transplant recipient\n- Women who are pregnant or breastfeeding\n- Unwilling to practice acceptable methods of birth control during study participation\n- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)\n- Currently receiving SGLT2-inhibitor\n- Concomitant treatment with steroids or any other immunosuppressive agent\n- Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose)\n- Ketoacidosis (laboratory based) in the past 5 years\n- Type 1 diabetes mellitus\n- Uncontrolled urinary tract- or genital infections\n- Inability to fully understand the possible risks and benefits related to study participation\n- Inability to undergo MRI exam (e.g. implanted medical devices)"}

Primary endpoints

• {"endpoint_text":"- Relative change from baseline total kidney volume (TKV) to month 18 of treatment (%/year).","definition_or_measurement_approach":"Change from baseline total kidney volume (TKV) to month 18 of treatment, reported as %/year."}

Germany

Earliest CTIS Part Ii Submission Date

26-02-2024

Latest Decision Or Authorization Date

05-03-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

44

Primary sponsor

Full Name

Medizinische Hochschule Hannover

Organisation Type

Educational Institution

Country Of Registered Address

Germany