Hydrochlorothiazide for Kidney Stone Recurrence Prevention

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03057431
• Date of registration: 15/02/2017
• Prospective Registration: Yes
• Primary sponsor: Insel Gruppe AG, University Hospital Bern
• Public title: Hydrochlorothiazide for Kidney Stone Recurrence Prevention NOSTONE
• Scientific title: Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis
• Date of first enrolment: March 9, 2017
• Target sample size: 416
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03057431
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Daniel Fuster, Prof MD
• Affiliation: Division of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nephrolithiasis

Intervention(s)

Drug: 25.0 mg hydrochlorothiazide

Drug: 12.5 mg hydrochlorothiazide

Drug: 50.0 mg hydrochlorothiazide

Drug: Placebo oral capsule

Primary Outcome(s)

Number of Participants With Stone Recurrences [Time Frame: After 3 years]

Secondary Outcome(s)

Number of Radiologic Stone Recurrences. [Time Frame: After 3 years]

Number of Symptomatic Stone Recurrences [Time Frame: After 3 years]

Secondary ID(s)

2016-01475

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/02/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03057431