Study of Empagliflozin in Patients with Autosomal Dominant Polycystic Kidney Disease

Phase 1

Recruiting

Conditions: Autosomal dominant polycystic kidney disease
MedDRA version: 20.0Level: LLTClassification code: 10032607Term: Other specified cystic kidney disease Class: 10010331
MedDRA version: 20.0Level: LLTClassification code: 10011771Term: Cystic kidney disease Class: 10010331
Therapeutic area: Not possible to specify

Registration Number: CTIS2023-505890-34-00

Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 44

Inclusion 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

Exclusion Criteria

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)