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

NCT06391450 | Active Not Recruiting Phase 4

• 1 other identifier: 2023-505890-3
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney

Outcome Measures

Primary Outcomes (1)

• Total kidney volume (TKV)

  Relative change from baseline TKV (percent/year) to month 18 of treatment.

  18 months

Secondary Outcomes (1)

• Estimated glomerular filtration rate (eGFR)

  18 months

Study Arms (2)

Empagliflozin 10 milligram (MG)

EXPERIMENTAL

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

Oral

Empagliflozin 10 milligram (MG)

Placebo DRUG

Oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Kidney or any other solid organ transplant recipient
• 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
• Ongoing 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)
• 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)

Sponsors & Collaborators

• Hannover Medical School: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

• Eswarappa M, Madden E, Shlipak MG, Cui X, Mrug M, Estrella MM, Park M. Sodium-Glucose Cotransporter-2 Inhibitor Therapy and Longitudinal Changes in Kidney Function among Veterans with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 May 16;20(7):940-949. doi: 10.2215/CJN.0000000725.

  PMID: 40377984 DERIVED

• Bahlmann-Kroll E, Hackl S, Kramer S, Wulfmeyer VC, Glandorf J, Kaufeld J, Koch A, Hartung D, Schmidt BMW, Schmidt-Ott K, Schmitt R. Empagliflozin in patients with autosomal dominant polycystic kidney disease (EMPA-PKD): study protocol for a randomised controlled trial. BMJ Open. 2024 Dec 15;14(12):e088317. doi: 10.1136/bmjopen-2024-088317.

  PMID: 39675824 DERIVED

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Roland SCHMITT, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 30, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)