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

ConditionAutosomal Dominant Polycystic Kidney Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCantonal Hospital Graubuenden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- 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

Trial design

Design model

Crossover

Treatments tested in this trial

Empagliflozin
Drug
Empagliflozin 10mg
Placebo
Drug
Placebo capsule

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Primary Outcome

\- Calcium, phosphate, magnesium excretion

Time frame

After a two week intervention

Secondary outcomes

Secondary Outcome

\- diuresis (24-hour urine volume, 24-hour creatinine, ketonuria, osmolarity, urinary pH) - tubular handling of other electrolytes (Na, K, Cl) - inflammation metabolism (CRP, hemoglobin?) - kidney function (creatinine, uric acid, urea, hemoglobin?) - effect on standardized blood pressure (assessed every two weeks) - bone metabolism (FGF23, PTH, 25-(OH)-D3) - tolerability (patient-reported side effects (nycturia, urinary urgency, lightheadedness, syncope) - safety (bacteriuria, urinary tract infection requiring antibiotic treatment, genital mycosis)

Time frame

After a two week intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cantonal Hospital Graubuenden

Lead sponsor

University of Zurich

Collaborator

Source ClinicalTrials.gov

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