Assessing empagliflozin for patients with autosomal dominant polycystic kidney disease

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

This study is testing if the drug empagliflozin can help people with a fast-progressing kidney disease feel better and slow down kidney damage.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hannover Medical School (Academic / other)
• Locations: 1 site (Hannover, Lower Saxony)
• Trial ID: NCT06391450 on ClinicalTrials.gov

What this trial studies

The EMPA-PKD trial evaluates the safety and efficacy of empagliflozin in patients with rapidly progressive autosomal dominant polycystic kidney disease (ADPKD), both with and without the use of tolvaptan. This double-blind, placebo-controlled study will randomly assign 44 participants to receive either empagliflozin or a placebo for 18 months. The primary focus is on monitoring changes in kidney volume through MRI and assessing the rate of kidney function decline. Secondary endpoints include evaluating glomerular filtration rate and other health markers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of rapid progressive ADPKD and specific kidney function criteria.

Not a fit: Patients with kidney transplants, those currently on SGLT2 inhibitors, or individuals with hypersensitivity to empagliflozin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that slows the progression of kidney disease in ADPKD patients.

How similar studies have performed: While SGLT2 inhibitors have shown promise in other conditions, this specific application in ADPKD is novel and has not been extensively tested.

Eligibility criteria

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)

Where this trial is running

Hannover, Lower Saxony

• Medizinische Hochschule Hannover — Hannover, Lower Saxony, Germany (Recruiting)

Study contacts

• Principal investigator: Roland SCHMITT, MD — Hannover Medical School
• Study coordinator: Elisabeth Bahlmann-Kroll

Conditions Autosomal Dominant Polycystic Kidney