Autosomal Dominant Polycystic Kidney Disease Clinical Trial
— SIDIAOfficial title:
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Cantonal Hospital Graubuenden | Chur | Graubuenden |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hospital Graubuenden | University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Outcome | - Ca2+, phosphate, Mg absolutely and measured by fractional excretions | After a two week intervention | |
Secondary | 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) | After a two week intervention |
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