Clinical Trials in Germany / NCT06391450
Active, not recruiting
Phase 4
Study of Empagliflozin in Patients With Autosomal Dominant Polycystic Kidney Disease (EMPA-PKD)
NCT06391450 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Autosomal Dominant Polycystic Kidney
Investigational drug(s) / intervention(s)
Empagliflozin 10 MG →Placebo
Empagliflozin 10 MG: Oral
Placebo: Oral
Study summary
The EMPA-PKD trial is assessing the safety of empagliflozin in patients with rapid progressive ADPKD with and without concomitant tolvaptan use by monitoring kidney growth and the rate of loss of kidney function.
Eligibility
Inclusion Criteria:
1. Male and female\* patients ≥ 18 of age
2. 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
3. ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed)
4. Mayo Class I C, D, E
5. 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.
6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
7. Evidence of signed written informed consent.
Exclusion criteria:
1. Kidney or any other solid organ transplant recipient
2. Currently receiving SGLT2-inhibitor
3. Concomitant treatment with steroids or any other immunosuppressive agent
4. Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose)
5. Ketoacidosis (laboratory based) in the past 5 years
6. Type 1 diabetes mellitus
7. Ongoing urinary tract- or genital infections
8. Inability to fully understand the possible risks and benefits related to study participation
9. Inability to undergo MRI exam (e.g. implanted medical devices)
10. Women who are pregnant or breastfeeding
11. Unwilling to practice acceptable methods of birth control during study participation
12. Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
Primary outcome measure(s)
- Total kidney volume (TKV) — 18 months
Relative change from baseline TKV (percent/year) to month 18 of treatment.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | Lower Saxony |
More Hannover Medical School trials in Germany
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06391450 on ClinicalTrials.gov ↗ ← All trials in Germany