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 |