Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT06435858
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06435858
Study Brief:
Protocol Section:
NCT06435858