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New treatment option for Autosomal Dominant Polycystic Kidney Disease
Official title Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
ClinicalTrials.gov ID: NCT06435858
What this study is testing
What is Empagliflozin?
Empagliflozin is an investigational medicine, being studied as a potential treatment for autosomal dominant polycystic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- \- Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital...
- Informed consent as documented by signature
You likely can't join 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)
See the full eligibility 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...
- Informed consent as documented by signature
- \- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
- Chur, Kanton Graubünden, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland; Chur, Kanton Graubünden, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.