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

NCT06435858 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-00070
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

phosphate; calcium; magnesium; Empagliflozin; ADPKD

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  \- Calcium, phosphate, magnesium excretion

  After a two week intervention

Secondary Outcomes (1)

• Secondary Outcome

  After a two week intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Empagliflozin 10mg

Drug: Empagliflozin

Control

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Empagliflozin DRUG

Empagliflozin 10mg

Intervention

Placebo DRUG

Placebo capsule

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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
• , 25 (OH) vitamin D (calcitriol)
• Bisphosphonate, denosumab, teriparatide
• Pregnant or lactating women
• Known allergy to study drug
• Inability to understand and follow the protocol

Sponsors & Collaborators

• Cantonal Hospital Graubuenden: lead
• University of Zurich: collaborator

Study Sites (2)

University Hospital Zurich, Division of Nephrology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Cantonal Hospital Graubuenden

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Related Publications (1)

• 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

• Thomas Fehr, MD

  Cantonal Hospital Graubuenden

  PRINCIPAL INVESTIGATOR

• Patrick Hofmann, MD

  Cantonal Hospital Graubuenden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Hofmann, MD

CONTACT

+4181 256 6305; hofmannpatrick@bluewin.ch

Thomas Fehr, MD

CONTACT

+4181 256 6305; medizin@ksgr.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigator-initiated randomised, single-blind, placebo-controlled, cross-over study

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)