Table 2.
Eligibility criteria of the NOSTONE study
| Inclusion criteria | |
| Individuals fulfilling all of the following inclusion criteria are eligible for study participation: | |
| - Informed Consent as documented by signature | |
| - Age 18 years or older | |
| - Recurrent kidney stone disease (≥ 2 stone events within the last 10 years prior to randomization) | |
| - Any past kidney stone containing 50% or more of calcium oxalate, calcium phosphate or a mixture of both | |
| Exclusion criteria | |
| The presence of any one of the following exclusion criteria will lead to exclusion of the individual: | |
| - Pharmacologic prevention for stone recurrence less than 3 months prior to randomization | |
| - Patients with secondary causes of recurrent calcareous nephrolithiasis including: | |
| - Severe eating disorders (anorexia or bulimia) | |
| - Chronic inflammatory bowel disease, bariatric surgery, intestinal surgery with malabsorbtion or chronic diarrhea | |
| - Sarcoidosis | |
| - Primary hyperparathyroidism | |
| - Complete distal tubular acidosis | |
| - Active malignancy | |
| - Patients with the following medications: | |
| - Thiazide or loop diuretics | |
| - Carbonic anhydrase inhibitors (including topiramate) | |
| - Xanthine oxidase inhibitors (febuxostat or allopurinol) | |
| - Alkali, including potassium citrate or sodium bicarbonate | |
| - 1,25 -OH Vitamin D (calcitriol) | |
| - Calcium supplementation | |
| - Bisphosphonates | |
| - Denusomab | |
| - Teriparatide | |
| - Glucocorticoids | |
| - Obstructive uropathy, if not treated successfully | |
| - Urinary tract infection, if not treated successfully | |
| - Chronic kidney disease (defined as CKD -EPI eGFR < 30 mL/min per 1,73 m2 body surface area) | |
| - Patients with a kidney transplant | |
| - > 3 gout arthritis episodes within one year prior to randomisation or gout arthritis requiring uric acid lowering therapy | |
| - Cystinuria at screening | |
| - Hypokalemia (blood potassium level < 3 mmol/L) at screening | |
| - Hyponatremia (blood sodium level < 125 mmol/L) at screening | |
| - Pregnant and lactating women | |
| - Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial | |
| - Inability to understand and follow the protocol | |
| - Known allergy to the study drug |