NephrolithiasisPhase 3NOSTONENCT03057431
Hydrochlorothiazide for Kidney Stone Recurrence Prevention
A Phase 3 study testing 12.5 mg hydrochlorothiazide, 25.0 mg hydrochlorothiazide and 50.0 mg hydrochlorothiazide in people with Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 12 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- 12.5 mg hydrochlorothiazide, 25.0 mg hydrochlorothiazide and 50.0 mg hydrochlorothiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 12 sitesSwitzerland
- Study dates
- 9 Mar 2017to 30 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 malabsorption or chronic diarrheal status
- Sarcoidosis
- Primary hyperparathyroidism
Show all 31Show fewer
- 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
- Treatment with 1,25-OH Vitamin D (calcitriol)
- Calcium supplementation
- Bisphosphonates
- Denosumab
- 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 for more than 3 months)
- 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 [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)]
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Kantonsspital Aarau
Aarau, 5001
University Hospital Basel
Basel, 4031
Ospedale Regionale di Bellinzona e Valli (San Giovanni)
Bellinzona, 6500
Bern University Hospital (Inselspital)
Bern, 3010
Kantonsspital Graubünden
Chur, 7000
Hôpitaux universitaires de Genève (HUG)
Geneva, 1205
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, 1011
Luzerner Kantonsspital
Lucerne, 6000
Ospedale Regionale di Lugano (Civico)
Lugano, 6900
Kantonsspital St. Gallen
Sankt Gallen, 9007
Hôpital de Sion
Sion, 1951
University Hospital Zürich
Zurich, 8091
About this study
Official title: Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis
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.
Read the detailed description
Nephrolithiasis is a global healthcare problem with a current lifetime risk of 18.8% in men and 9.4% in women. Without specific treatment, 5- and 20-year recurrence rates are 40% and 75%, respectively. Given the high cost of medical treatments and surgical interventions as well as the morbidity related to symptomatic stone disease, medical prophylaxis for stone recurrence is an attractive approach.
About 80-90% of stones are composed of calcium oxalate with various admixtures of calcium phosphate. Increased excretion of calcium in the urine, hypercalciuria, is the most common metabolic abnormality encountered in patients with recurrent nephrolithiasis. Thiazide diuretics have been the cornerstone of pharmacologic metaphylaxis for more than 40 years. The effect of thiazides to reduce the risk of stone recurrence has been attributed to their ability to decrease urinary calcium excretion. However, other factors, such as reduction of urinary pH and urinary oxalate excretion, probably contribute to this effect. Efficacy of thiazides on recurrence prevention of calcareous nephrolithiasis was tested in 11 randomized controlled trials (RCTs). With the exception of two trials, thiazides significantly reduced stone recurrence. Most of these trials are from the 1980's and 90's and the cumulative number of patients studied is remarkably low for such a prevalent disease. Our systematic review of these RCTs revealed major methodological deficiencies in all trials, including: lack of double-blinding and intention-to-treat analysis, unclear allocation concealment, lack of adverse event and drop out reporting and unknown baseline risk of disease severity. Furthermore, high doses of thiazides were employed in all trials, in the case of the best studied thiazide, hydrochlorothiazide (HCTZ), up to 100 mg daily. At such high doses, side effects occur frequently. Nowadays, thiazides are widely used in the treatment of recurrent nephrolithiasis and arterial hypertension, but at significantly lower doses. In the case of recurrent nephrolithiasis, however, this practice is not supported by randomized evidence and consequently, the investigators do not know whether the currently employed low dose thiazide regimens are effective in reducing the risk for stone recurrence.
Thus, evidence for benefits and harms of thiazide diuretics in the prevention of calcium-containing kidney stones in general remains unclear. In addition, the efficacy of the currently employed low dose thiazide regimens to prevent stone recurrence is not known.
- Conditions
- Nephrolithiasis
- Being tested
- Placebo oral capsule, 12.5 mg hydrochlorothiazide, 25.0 mg hydrochlorothiazide, 50.0 mg hydrochlorothiazide
- Keywords
- kidney stones, hydrochlorothiazide
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Once daily for 3 years
12.5 mg hydrochlorothiazideDrug
Once daily for 3 years
25.0 mg hydrochlorothiazideDrug
Once daily for 3 years
50.0 mg hydrochlorothiazideDrug
Once daily for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Once daily for 3 years Receives: Drug: Placebo oral capsule |
| 12.5 mg hydrochlorothiazide | Experimental | Once daily for 3 years Receives: Drug: 12.5 mg hydrochlorothiazide |
| 25.0 mg hydrochlorothiazide | Experimental | Once daily for 3 years Receives: Drug: 25.0 mg hydrochlorothiazide |
| 50.0 mg hydrochlorothiazide | Experimental | Once daily for 3 years Receives: Drug: 50.0 mg hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 years
Secondary outcomes (2)
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.
Measured: After 3 years
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).
Measured: After 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start9 Mar 2017
- Primary completion3 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Fuster, Prof MD, Principal investigator, Division of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057431
- Sponsor's protocol ID
- 2016-01475
- Other IDs
- 2016
- Acronym
- NOSTONE
- Status last verified
- Jan 2024
- First submitted
- 15 Feb 2017
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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, Roumet M, Tamo L, Cereghetti GM, Trelle S, Fuster DG. Hydrochlorothiazide and Prevention of Kidney-Stone Recurrence. N Engl J Med. 2023 Mar 2;388(9):781-791. doi: 10.1056/NEJMoa2209275.
PubMed 36856614Wiseman OJ, Turney BW. Does bespoke metabolic investigation reduce urinary stone recurrence? A narrative review. BJU Int. 2026 Oct 20. doi: 10.1111/bju.70500. Online ahead of print.
PubMed 42901875Stritt K, Fuster DG, Dhayat NA, Bonny O, Faller N, Christe A, Taha A, Ochs V, Ortlieb N, Roth B; on behalf of the NOSTONE Study. Risk Factors of Asymptomatic Kidney Stone Passage in Adults with Recurrent Kidney Stones. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1130-1137. doi: 10.2215/CJN.0000000000000496. Epub 2024 Jul 19.
PubMed 39028573Dhayat NA, Faller N, Bonny O, Mohebbi N, Ritter A, Pellegrini L, Bedino G, Schonholzer C, Venzin RM, Husler C, Koneth I, Del Giorno R, Gabutti L, Amico P, Mayr M, Odermatt U, Buchkremer F, Ernandez T, Stoermann-Chopard C, Teta D, Rintelen F, Roumet M, Irincheeva I, Trelle S, Tamo L, Roth B, Vogt B, Fuster DG. 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. BMC Nephrol. 2018 Dec 10;19(1):349. doi: 10.1186/s12882-018-1144-6.
PubMed 30526528
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Placebo-controlled Trial Assessing the Efficacy of Standard and Low Dose Hydrochlorothiazide Treatment in the Prevention of Recurrent Nephrolithiasis
- ClinicalTrials.gov ID
- NCT03057431
- Acronym / sponsor ID
- NOSTONE / 2016-01475
- Conditions
- Nephrolithiasis
- Keywords
- kidney stones, hydrochlorothiazide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nephrolithiasis is a global healthcare problem with a current lifetime risk of 18.8% in men and 9.4% in women. Without specific treatment, 5- and 20-year recurrence rates are 40% and 75%, respectively. Given the high cost of medical treatments and surgical interventions as well as the morbidity related to symptomatic stone disease, medical prophylaxis for stone recurrence is an attractive approach.
About 80-90% of stones are composed of calcium oxalate with various admixtures of calcium phosphate. Increased excretion of calcium in the urine, hypercalciuria, is the most common metabolic abnormality encountered in patients with recurrent nephrolithiasis. Thiazide diuretics have been the cornerstone of pharmacologic metaphylaxis for more than 40 years. The effect of thiazides to reduce the risk of stone recurrence has been attributed to their ability to decrease urinary calcium excretion. However, other factors, such as reduction of urinary pH and urinary oxalate excretion, probably contribute to this effect. Efficacy of thiazides on recurrence prevention of calcareous nephrolithiasis was tested in 11 randomized controlled trials (RCTs). With the exception of two trials, thiazides significantly reduced stone recurrence. Most of these trials are from the 1980's and 90's and the cumulative number of patients studied is remarkably low for such a prevalent disease. Our systematic review of these RCTs revealed major methodological deficiencies in all trials, including: lack of double-blinding and intention-to-treat analysis, unclear allocation concealment, lack of adverse event and drop out reporting and unknown baseline risk of disease severity. Furthermore, high doses of thiazides were employed in all trials, in the case of the best studied thiazide, hydrochlorothiazide (HCTZ), up to 100 mg daily. At such high doses, side effects occur frequently. Nowadays, thiazides are widely used in the treatment of recurrent nephrolithiasis and arterial hypertension, but at significantly lower doses. In the case of recurrent nephrolithiasis, however, this practice is not supported by randomized evidence and consequently, the investigators do not know whether the currently employed low dose thiazide regimens are effective in reducing the risk for stone recurrence.
Thus, evidence for benefits and harms of thiazide diuretics in the prevention of calcium-containing kidney stones in general remains unclear. In addition, the efficacy of the currently employed low dose thiazide regimens to prevent stone recurrence is not known.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral capsuleOnce daily for 3 years |
| 12.5 mg hydrochlorothiazide | Experimental | Drug: 12.5 mg hydrochlorothiazideOnce daily for 3 years |
| 25.0 mg hydrochlorothiazide | Experimental | Drug: 25.0 mg hydrochlorothiazideOnce daily for 3 years |
| 50.0 mg hydrochlorothiazide | Experimental | Drug: 50.0 mg hydrochlorothiazideOnce daily for 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (31 listed)
- Pharmacologic prevention for stone recurrence less than 3 months prior to randomization
- Patients with secondary causes of recurrent calcareous nephrolithiasis including:
- Patients with the following medications:
- Obstructive uropathy, if not treated successfully
- Urinary tract infection, if not treated successfully
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral capsuleOnce daily for 3 years | Drug | Placebo |
| 12.5 mg hydrochlorothiazideOnce daily for 3 years | Drug | 12.5 mg hydrochlorothiazide |
| 25.0 mg hydrochlorothiazideOnce daily for 3 years | Drug | 25.0 mg hydrochlorothiazide |
| 50.0 mg hydrochlorothiazideOnce daily for 3 years | Drug | 50.0 mg hydrochlorothiazide |
Primary outcome
Number of Participants With Stone Recurrences
Time frame: After 3 years
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.
2 secondary outcomes
Number of Symptomatic Stone Recurrences
Time frame: After 3 years
Number of Radiologic Stone Recurrences.
Time frame: After 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36856614Dhayat 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, Roumet M, Tamo L, Cereghetti GM, Trelle S, Fuster DG. Hydrochlorothiazide and Prevention of Kidney-Stone Recurrence. N Engl J Med. 2023 Mar 2;388(9):781-791. doi: 10.1056/NEJMoa2209275.
- Derived from this study: PubMed 42901875Wiseman OJ, Turney BW. Does bespoke metabolic investigation reduce urinary stone recurrence? A narrative review. BJU Int. 2026 Oct 20. doi: 10.1111/bju.70500. Online ahead of print.
- Derived from this study: PubMed 39028573Stritt K, Fuster DG, Dhayat NA, Bonny O, Faller N, Christe A, Taha A, Ochs V, Ortlieb N, Roth B; on behalf of the NOSTONE Study. Risk Factors of Asymptomatic Kidney Stone Passage in Adults with Recurrent Kidney Stones. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1130-1137. doi: 10.2215/CJN.0000000000000496. Epub 2024 Jul 19.
- Derived from this study: PubMed 30526528Dhayat NA, Faller N, Bonny O, Mohebbi N, Ritter A, Pellegrini L, Bedino G, Schonholzer C, Venzin RM, Husler C, Koneth I, Del Giorno R, Gabutti L, Amico P, Mayr M, Odermatt U, Buchkremer F, Ernandez T, Stoermann-Chopard C, Teta D, Rintelen F, Roumet M, Irincheeva I, Trelle S, Tamo L, Roth B, Vogt B, Fuster DG. 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. BMC Nephrol. 2018 Dec 10;19(1):349. doi: 10.1186/s12882-018-1144-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fuster, Prof MD principal investigator
Division of Nephrology and Hypertension, Bern University Hospital, Bern, Switzerland
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 12.5 mg hydrochlorothiazide, 25.0 mg hydrochlorothiazide and 50.0 mg hydrochlorothiazide in people with Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 12 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Stone Recurrences (time frame: After 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057431, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.