Kidney Stones, Urolithiasis, HypocitraturiaPhase 1/2NCT07408076
Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones
A Phase 1/2 study testing Potassium Citrate and Sodium Bicarbonate in people with Kidney Stones, Urolithiasis, Hypocitraturia and Nephrolithiasis, run by University of California, Los Angeles at 6 sites in 3 countries.
Trial summary
Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Urolithiasis, Hypocitraturia, Nephrolithiasis
- What is being tested?
- Potassium Citrate and Sodium Bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Adult >18 years of age
- History of nephrolithiasis
- One 24h urine collections within one year of enrollment with hypocitraturia.
- Patients currently utilizing or considering use of Kcit for stone prevention
Who cannot join
- Individuals with known metabolic disorders
- Individuals with other known causes of nephrolithiasis
- Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Janelly B Jimenez contact
6 sites in 3 countries
United States4 sites
Brigham & Women's
Boston, Massachusetts, 02115
Daniel Wolen
University of California, Los Angeles
Los Angeles, California, 90095
University of California, Davis
Sacramento, California, 95817
Noah Canvasser
University of California, San Diego
San Diego, California, 92103
Seth Bechis
Iceland1 site
Landspitali- National University Hospital of Iceland
Reykjavik
Johann Ingimarsson
About this study
Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.
Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.
This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.
Read the detailed description
Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.
Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.
A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.
- Being tested
- Potassium Citrate, Sodium Bicarbonate
- Keywords
- kidney stone, stone, calcium oxalate, calcium phosphate, potassium citrate, sodium bicarbonate, nephrolithiasis
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium CitrateDrug
20 mEq Kcit twice a day (40 mEq daily
Sodium BicarbonateDrug
650 mg sodium bicarbonate twice a day (35.2 mEq daily)
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate -> Potassium Citrate | Experimental | Receives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout. Receives: Drug: Potassium Citrate; Drug: Sodium Bicarbonate |
| Potassium Citrate -> Sodium Bicarbonate | Experimental | 1 week of potassium citrate first, then sodium bicarbonate after a washout. Receives: Drug: Potassium Citrate; Drug: Sodium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection
Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention.
To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10
Unit: mg/day
Measured: 14 days
Secondary outcomes (2)
Change in Urine pH Measured from 24-Hour Urine Collection
Change in urine pH measured from 24 hour urine collections obtained at baseline and after intervention
units: pH
Measured: 14 days
Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection
Change in 24 hour urinary ammonia excretion from 24 hour urine collections obtained at baseline and after intervention
Unit: mmol/day
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney Stones, Urolithiasis, HypocitraturiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. Patients with confirmed hypocitraturia identified and enrolled in study 2. Pre-study medical history and laboratory data will be recorded, and 24 hour urine will be obtained 3. Set diet will be followed x 48hrs while on first treatment (sodium bicarbonate or potassium citrate; order randomized for 50:50 chance) for at least 1 week 4. 24 Hour urine performed during 2nd day of set diet 5. 1 week washout 6. 1 week use of other medication (sodium bicarbonate or potassium citrate) 7. Set diet will be followed x 48hrs while on potassium citrate 8. 24 Hour urine performed during 2nd day of set diet 9. Change in citrate, pH, and ammonia will be recorded.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Brigham and Women's Hospital, Landspitali University Hospital, University of California, San Diego, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Principal investigator, Kymora Scotland, MD, PhD, University of California, Los Angeles
- Investigators
- Kymora B Scotland, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408076
- Sponsor's protocol ID
- IRB-24-5580
- Other IDs
- IRB-24-5580
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this study, along with the Study Protocol and Statistical Analysis Plan, will be made available to qualified researchers upon request. Interested parties should direct their inquiries and research proposals to KScotland@mednet.ucla.edu. To gain access, requestors will be required to provide a methodologically sound proposal and sign a formal Data Use Agreement (DUA) to ensure participant confidentiality. Data will be available beginning 6 months after the publication of the primary results and will remain accessible for a period of 3 years. The study team will review all requests to determine if the proposed use of the data aligns with the original study's ethical approvals and scientific objectives.
Publications
Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.
PubMed 36261757Pinheiro VB, Baxmann AC, Tiselius HG, Heilberg IP. The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers. Urology. 2013 Jul;82(1):33-7. doi: 10.1016/j.urology.2013.03.002. Epub 2013 Apr 18.
PubMed 23602798Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Factors Associated With Preventive Pharmacological Therapy Adherence Among Patients With Kidney Stones. Urology. 2016 Jul;93:45-9. doi: 10.1016/j.urology.2016.03.030. Epub 2016 Mar 31.
PubMed 27041472Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20.
PubMed 24857648Pearle MS, Roehrborn CG, Pak CY. Meta-analysis of randomized trials for medical prevention of calcium oxalate nephrolithiasis. J Endourol. 1999 Nov;13(9):679-85. doi: 10.1089/end.1999.13.679.
PubMed 10608521Barcelo P, Wuhl O, Servitge E, Rousaud A, Pak CY. Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. J Urol. 1993 Dec;150(6):1761-4. doi: 10.1016/s0022-5347(17)35888-3.
PubMed 8230497Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
PubMed 9366314Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
PubMed 2688503Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
PubMed 22498635
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate as an Alternative to Potassium Citrate for Kidney Stones
- ClinicalTrials.gov ID
- NCT07408076
- Acronym / sponsor ID
- IRB-24-5580
- Keywords
- kidney stone, stone, calcium oxalate, calcium phosphate, potassium citrate, sodium bicarbonate, nephrolithiasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California, Davis, Brigham and Women's Hospital, Landspitali University Hospital, University of California, San Diego, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney stones affect 1 in every 11 people in the US each year. In patients with kidney stones who are prescribed medications for stone management, only 30.2% are adherent to a medication regime and even fewer, only 13.4 % are adherent with citrate medications.
Prescription potassium citrate can be expensive for many patients, leading to non-compliance. Sodium bicarbonate is a potential medication alternative that is cheaper and can potentially alkalinize the urine and/or decrease the risk of future kidney stones. However, efficacy of alternatives to potassium potassium citrate are not well studied.
This study seeks to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of patients with kidney stones and compare this to prescription potassium citrate.
Detailed description
Kidney stones affect 1 in every 11 people in the United States each year. A recurrence rate of 50% at 10 years highlights the importance of metabolic management, which has shown to be effective at decreasing the recurrence of stone disease. Specialty guidelines have recommended that clinicians offer pharmacologic therapy to recurrent stone formers. However, among kidney stone patients prescribed medication for stone management, only 30.2% are adherent to a medication regimen and even fewer, only 13.4%, are adherent with citrate medications.
Prescription potassium citrate (Kcit) can be cost-prohibitive for many patients, leading to non-compliance. The combination of the effectiveness of medication with the prohibitory cost of the prescriptions has led to the exploration of treatment alternatives which promise to alkalinize the urine and/or decrease the risk of future kidney stones, including sodium bicarbonate. However, the efficacy of these alternatives in comparison to Kcit are not well studied and often include other alkali equivalents.
A short-term study with limited sample size suggests sodium bicarbonate to be a viable alternative to Kcit. Our goal is to evaluate sodium bicarbonate and assess its ability to alkalinize urine in a cohort of stone-forming patients and compare this to prescription Kcit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Patients with confirmed hypocitraturia identified and enrolled in study 2. Pre-study medical history and laboratory data will be recorded, and 24 hour urine will be obtained 3. Set diet will be followed x 48hrs while on first treatment (sodium bicarbonate or potassium citrate; order randomized for 50:50 chance) for at least 1 week 4. 24 Hour urine performed during 2nd day of set diet 5. 1 week washout 6. 1 week use of other medication (sodium bicarbonate or potassium citrate) 7. Set diet will be followed x 48hrs while on potassium citrate 8. 24 Hour urine performed during 2nd day of set diet 9. Change in citrate, pH, and ammonia will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate -> Potassium Citrate | Experimental | Drug: Potassium Citrate, Drug: Sodium BicarbonateReceives 1 week of sodium bicarbonate, then 1 week of potassium citrate after washout. |
| Potassium Citrate -> Sodium Bicarbonate | Experimental | Drug: Potassium Citrate, Drug: Sodium Bicarbonate1 week of potassium citrate first, then sodium bicarbonate after a washout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult >18 years of age
- History of nephrolithiasis
- One 24h urine collections within one year of enrollment with hypocitraturia.
- Patients currently utilizing or considering use of Kcit for stone prevention
Key exclusion criteria (3 listed)
- Individuals with known metabolic disorders
- Individuals with other known causes of nephrolithiasis
- Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study
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 |
|---|---|---|
| Potassium Citrate20 mEq Kcit twice a day (40 mEq daily | Drug | Potassium Citrate -> Sodium Bicarbonate, Sodium Bicarbonate -> Potassium Citrate |
| Sodium Bicarbonate650 mg sodium bicarbonate twice a day (35.2 mEq daily) | Drug | Potassium Citrate -> Sodium Bicarbonate, Sodium Bicarbonate -> Potassium Citrate |
Primary outcome
Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection
Time frame: 14 days
Change in 24-hour urinary citrate excretion measured from 24-hour urine collections obtained at baseline and after intervention. To determine if sodium bicarbonate is not significantly worse than potassium citrate by more than a clinically acceptable margin of -10 Unit: mg/day
2 secondary outcomes
Change in Urine pH Measured from 24-Hour Urine Collection
Time frame: 14 days
Change in 24 hour Urinary Ammonia Excretion from 24 Hour Urine Collection
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 36261757Xue W, Cheng J, Zhao J, Wang L, Peng A, Liu X. Comparison potassium sodium hydrogen citrate with sodium bicarbonate in urine alkalization: a prospective crossover-controlled trial. Int Urol Nephrol. 2023 Jan;55(1):61-68. doi: 10.1007/s11255-022-03387-y. Epub 2022 Oct 19.
- Background: PubMed 23602798Pinheiro VB, Baxmann AC, Tiselius HG, Heilberg IP. The effect of sodium bicarbonate upon urinary citrate excretion in calcium stone formers. Urology. 2013 Jul;82(1):33-7. doi: 10.1016/j.urology.2013.03.002. Epub 2013 Apr 18.
- Background: PubMed 27041472Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Factors Associated With Preventive Pharmacological Therapy Adherence Among Patients With Kidney Stones. Urology. 2016 Jul;93:45-9. doi: 10.1016/j.urology.2016.03.030. Epub 2016 Mar 31.
- Background: PubMed 24857648Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20.
- Background: PubMed 10608521Pearle MS, Roehrborn CG, Pak CY. Meta-analysis of randomized trials for medical prevention of calcium oxalate nephrolithiasis. J Endourol. 1999 Nov;13(9):679-85. doi: 10.1089/end.1999.13.679.
- Background: PubMed 8230497Barcelo P, Wuhl O, Servitge E, Rousaud A, Pak CY. Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. J Urol. 1993 Dec;150(6):1761-4. doi: 10.1016/s0022-5347(17)35888-3.
- Background: PubMed 9366314Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
- Background: PubMed 2688503Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
- Background: PubMed 22498635Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this study, along with the Study Protocol and Statistical Analysis Plan, will be made available to qualified researchers upon request. Interested parties should direct their inquiries and research proposals to KScotland@mednet.ucla.edu. To gain access, requestors will be required to provide a methodologically sound proposal and sign a formal Data Use Agreement (DUA) to ensure participant confidentiality. Data will be available beginning 6 months after the publication of the primary results and will remain accessible for a period of 3 years. The study team will review all requests to determine if the proposed use of the data aligns with the original study's ethical approvals and scientific objectives.
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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.
Janelly B Jimenez contact
Kymora B Scotland, MD, PhD principal investigator
University of California, Los Angeles
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Potassium Citrate and Sodium Bicarbonate in people with Kidney Stones, Urolithiasis, Hypocitraturia and Nephrolithiasis, run by University of California, Los Angeles at 6 sites in 3 countries.
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 3 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Iceland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janelly B Jimenez (JBJimenez@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-Hour Urinary Citrate Excretion from 24-Hour Urine Collection (time frame: 14 days). 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 NCT07408076, which also lists 9 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 12 Feb 2026.