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

Launched by CANTONAL HOSPITAL GRAUBUENDEN · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Empagliflozin on patients with autosomal dominant polycystic kidney disease (ADPKD). The aim is to understand how this medication affects the balance of important minerals in the body, such as calcium, phosphate, and magnesium. Participants will be randomly assigned to either take Empagliflozin or a placebo (a harmless pill with no active medication) for two weeks. After a two-week break, they will switch to the other treatment. Researchers will monitor how well participants' bodies handle these minerals, as well as check for any side effects or issues during the study.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of ADPKD. They should not be on certain medications or have other serious health conditions, such as advanced kidney disease or uncontrolled high blood pressure. Participants will need to visit the hospital for check-ups, and they will be asked to stop specific medications during the study. This trial is currently recruiting patients, and it offers an opportunity to contribute to important research that could improve treatment options for those with ADPKD.

Gender

ALL

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