Effects of Empagliflozin on Electrolytes in Kidney Disease
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
This study is testing if the medication Empagliflozin can change how the body handles important minerals in people with a specific type of kidney disease called ADPKD.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cantonal Hospital Graubuenden Academic / other |
| Drugs / interventions | denosumab |
| Locations | 2 sites (Zurich, Canton of Zurich and 1 other locations) |
| Trial ID | NCT06435858 on ClinicalTrials.gov |
What this trial studies
This study investigates how the SGLT2 inhibitor Empagliflozin affects the handling of divalent ions such as calcium, phosphate, and magnesium in patients with autosomal dominant polycystic kidney disease (ADPKD). Participants will be randomly assigned to receive either Empagliflozin or a placebo for two weeks, followed by a wash-out period and then a crossover to the alternate treatment. The primary focus is on measuring tubular handling of these electrolytes through 24-hour urine samples and blood tests at various intervals. Safety and tolerability will also be assessed through phone consultations during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of ADPKD who are not on renal replacement therapy.
Not a fit: Patients with advanced chronic kidney disease, those on renal replacement therapy, or with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of electrolyte imbalances in patients with ADPKD, potentially enhancing their overall kidney health.
How similar studies have performed: While the use of SGLT2 inhibitors in kidney disease is gaining attention, this specific approach to studying electrolyte handling in ADPKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich, Canton of Zurich and 1 other locations
- University Hospital Zurich, Division of Nephrology — Zurich, Canton of Zurich, Switzerland (Recruiting)
- Cantonal Hospital Graubuenden — Chur, Kanton Graubünden, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thomas Fehr, MD — Cantonal Hospital Graubuenden
- Study coordinator: Patrick Hofmann, MD
- Email: hofmannpatrick@bluewin.ch
- Phone: +4181 256 6305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.