Nephrolithiasis Clinical Trial
— NOSTONEOfficial title:
Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis
Verified date | January 2024 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan to assess the efficacy of standard and low dose HCTZ treatment in the recurrence prevention of calcium-containing kidney stones. More specifically, the investigators aim to assess the dose-response relationship for three different dosages of HCTZ. Study intervention: HCTZ 12.5 mg, 25 mg or 50 mg once daily per os for 24 or 36 months. In addition, all patients in HCTZ treatment arms will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines. Control intervention: Placebo once daily per os for 24 to 36 months. In addition, all patients in the placebo arm will receive state-of-the-art non-pharmacologic recommendations for stone prevention according to current guidelines.
Status | Completed |
Enrollment | 416 |
Est. completion date | April 30, 2022 |
Est. primary completion date | December 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Informed Consent as documented by signature 2. Age 18 years or older 3. Recurrent kidney stone disease (= 2 stone events within the last 10 years prior to randomization) 4. Any past kidney stone containing 50% or more of calcium oxalate, calcium phosphate or a mixture of both Exclusion Criteria: 1. Pharmacologic prevention for stone recurrence less than 3 months prior to randomization 2. Patients with secondary causes of recurrent calcareous nephrolithiasis including: - Severe eating disorders (anorexia or bulimia) - Chronic inflammatory bowel disease, bariatric surgery, intestinal surgery with malabsorption or chronic diarrheal status - Sarcoidosis - Primary hyperparathyroidism - Complete distal tubular acidosis - Active malignancy 3. 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 - Treatment with 1,25-OH Vitamin D (calcitriol) - Calcium supplementation - Bisphosphonates - Denosumab - Teriparatide - Glucocorticoids 4. Obstructive uropathy, if not treated successfully 5. Urinary tract infection, if not treated successfully 6. Chronic kidney disease (defined as CKD-EPI eGFR < 30 mL/min per 1,73 m2 body surface area for more than 3 months) 7. Patients with a kidney transplant 8. > 3 gout arthritis episodes within one year prior to randomisation or gout arthritis requiring uric acid lowering therapy 9. Cystinuria at screening 10. Hypokalemia (blood potassium level < 3 mmol/L) at screening 11. Hyponatremia (blood sodium level < 125 mmol/L) at screening 12. Pregnant and lactating women [pregnancy test to be performed for women of child-bearing potential (defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months)] 13. Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial 14. Inability to understand and follow the protocol 15. Known allergy to the study drug |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital Aarau | Aarau | |
Switzerland | University Hospital Basel | Basel | |
Switzerland | Ospedale Regionale di Bellinzona e Valli (San Giovanni) | Bellinzona | |
Switzerland | Bern University Hospital (Inselspital) | Bern | |
Switzerland | Kantonsspital Graubünden | Chur | |
Switzerland | Hôpitaux universitaires de Genève (HUG) | Geneve | |
Switzerland | Centre hospitalier universitaire vaudois (CHUV) | Lausanne | |
Switzerland | Ospedale Regionale di Lugano (Civico) | Lugano | |
Switzerland | Luzerner Kantonsspital | Luzern | |
Switzerland | Hôpital de Sion | Sion | |
Switzerland | Kantonsspital St. Gallen | St.Gallen | |
Switzerland | University Hospital Zürich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Dhayat NA, Bonny O, Roth B, Christe A, Ritter A, Mohebbi N, Faller N, Pellegrini L, Bedino G, Venzin RM, Grosse P, Husler C, Koneth I, Bucher C, Del Giorno R, Gabutti L, Mayr M, Odermatt U, Buchkremer F, Ernandez T, Stoermann-Chopard C, Teta D, Vogt B, Ro — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Stone Recurrences | Composite of symptomatic or radiological recurrences, defined as either a symptomatic kidney stone passage or radiological kidney stone recurrence on CT.
Symptomatic recurrence was defined as the visible passage of a stone with or without accompanying typical symptoms (such as flank or loin pain and hematuria) or as the presence of a symptomatic or asymptomatic stone that was determined to require surgical removal. If a patient had symptoms during the trial that were suggestive of a possible stone passage but no visible stone had been observed, local investigators evaluated the symptoms of the patient and judged whether a stone passage had occurred. Radiological recurrence was defined as a new stone formed or enlargement of a preexisting stone. |
After 3 years | |
Secondary | Number of Symptomatic Stone Recurrences | Symptomatic recurrence was defined as the visible passage of a stone with or without accompanying typical symptoms (such as flank or loin pain and hematuria) or as the presence of a symptomatic or asymptomatic stone that was determined to require surgical removal. If a patient had symptoms during the trial that were suggestive of a possible stone passage but no visible stone had been observed, local investigators evaluated the symptoms of the patient and judged whether a stone passage had occurred. | After 3 years | |
Secondary | Number of Radiologic Stone Recurrences. | Radiological stone recurrence was defined as a new stone formed or enlargement of a preexisting stone (assessed by low-dose CT of the kidney at the end of the study compared to the low-dose CT of the kidney at the baseline visit). | After 3 years |
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