Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease

NCT ID: NCT06435858

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-10-31

Brief Summary

This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.

Detailed Description

This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.

After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.

At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.

At week 3 & 7, a phone consultation will assess safety.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Empagliflozin 10mg

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10mg

Control

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule

Interventions

Empagliflozin

Empagliflozin 10mg

Intervention Type: DRUG

Placebo

Placebo capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
• Informed consent as documented by signature

Exclusion Criteria

• - renal replacement therapy or kidney allograft recipient
• chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
• patients younger 18 years of age
• Diabetes mellitus type 1
• recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
• Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
• Patients not able or not willing to stop the following medications during the study period of participation in the trial:
• Thiazide diuretics
• Carbonic anhydrase inhibitors
• Sodium bicarbonate
• 1, 25 (OH) vitamin D (calcitriol)
• Bisphosphonate, denosumab, teriparatide
• Pregnant or lactating women
• Known allergy to study drug
• Inability to understand and follow the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Cantonal Hospital Graubuenden

OTHER

Sponsor Role: lead

Responsible Party

Patrick Hofmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Fehr, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Graubuenden

Patrick Hofmann, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Graubuenden

Locations

University Hospital Zurich, Division of Nephrology

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Cantonal Hospital Graubuenden

Chur, Kanton Graubünden, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Patrick Hofmann, MD

Role: CONTACT

hofmannpatrick@bluewin.ch

+4181 256 6305

Thomas Fehr, MD

Role: CONTACT

medizin@ksgr.ch

+4181 256 6305

Facility Contacts

Thomas Schachtner, MD

Role: primary

Patrick Hofmann, MD

Role: primary

medizin@ksgr.ch

References

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.

Reference Type: DERIVED

PMID: 39356039 (View on PubMed)

Other Identifiers

2024-00070

Identifier Type: -

Identifier Source: org_study_id