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Table 2 Eligibility criteria of the NOSTONE study

From: Efficacy of standard and low dose hydrochlorothiazide in the recurrence prevention of calcium nephrolithiasis (NOSTONE trial): protocol for a randomized double-blind placebo-controlled trial

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