Diabetes drug repurposed to fight polycystic kidney disease
NCT ID NCT06391450
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 4 trial tests whether empagliflozin, a diabetes drug, can safely slow kidney growth and preserve kidney function in 44 adults with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Participants take either empagliflozin or a placebo for 18 months, and some also take the standard drug tolvaptan. The goal is to see if adding empagliflozin helps protect the kidneys.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin
- What this could lead to
- If it works, this could offer a new way to slow kidney enlargement and preserve kidney function in people with polycystic kidney disease.
- What could go wrong
- This is a small, early-phase trial with only 44 participants, so results may not apply to everyone. The drug may not show a clear benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
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