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

Autosomal Dominant Polycystic Kidney Clinical Trial

— EMPA-PKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391450
• Other study ID #: 2023-505890-3
• Status: Recruiting
• Phase: Phase 4
• Start date: June 14, 2024
• Est. completion date: May 2027

Study information

• Verified date: June 2024
• Source: Hannover Medical School
• Contact: Elisabeth Bahlmann-Kroll
• Phone: +495115323000
• Email: studienzentrum[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In autosomal dominant polycystic kidney disease (ADPKD) formation of cysts in the kidneys causes destruction of functional parenchyma and loss of kidney function, which may progress to end-stage kidney disease. Tolvaptan is the only drug specifically approved for slowing down the progression of ADPKD. Sodium glucose cotransporter 2 inhibitors (SGLT2i) might provide additional benefits but there is currently no information on safety and outcome effects of SGLT2i in patients with ADPKD, as these patients were excluded in the landmark SGLT2i trials. In an investigator-initiated, double-blind, mono-center, placebo-controlled, randomized clinical trial the EMPA-PKD study 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.

44 participants will be randomly allocated (1:1) to receive a daily dose of either empagliflozin (10 mg/day) or placebo for 18 months. Patients will be stratified according to concomitant tolvaptan use. The primary endpoint is progression of cystic kidney growth by monitoring MRI-based changes in total kidney volume and the secondary endpoint is exploring changes in glomerular filtration rate. Additional endpoints include adverse events and changes in copeptin levels, albuminuria and blood pressure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Arthrogryposis
• Autosomal Dominant Polycystic Kidney
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Empagliflozin 10 MG
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total kidney volume (TKV)	Relative change from baseline TKV (percent/year) to month 18 of treatment.	18 months
Secondary	Estimated glomerular filtration rate (eGFR)	Change in the eGFR from baseline to month 18 of treatment	18 months