Kidney StoneEarly Phase 1NCT04651088
Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet
A Early Phase 1 study testing Potassium citrate, Sodium bicarbonate and Litholyte in people with Kidney Stone, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Potassium citrate, Sodium bicarbonate and Litholyte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Jul 2027
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older.
- with or without a history of stone disease.
Who cannot join
- They are unable to take any of the medications due to health reasons.
- Participants are pregnant or nursing.
- Participants are unable to adhere to the metabolic diet.
- Participants had a prior adverse event from one or more of the medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Gonzalez, MD contact
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Brett Johnson, MD, 2146486853, brett.johnson@utsouthwestern.edu
About this study
Official title: Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet
The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
Read the detailed description
Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.
One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.
The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.
- Conditions
- Kidney Stone
- Being tested
- Potassium citrate, Sodium bicarbonate, Litholyte, Crystal Lite, Potassium Bicarbonate
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium citrateDrug
Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
Sodium bicarbonateDrug
650mg tabs. Take 3 tabs twice daily.
LitholyteDietary supplement
One packet is taken with 170ml of water. Two packets daily.
Crystal LiteDietary supplement
The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.
Potassium BicarbonateDrug
20 mEq tablets, one tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metabolic diet | Placebo comparator | Controlled metabolic diet arm. Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
| Potassium citrate | Active comparator | Not described Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
| Sodium Bicarbonate | Active comparator | Not described Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
| Litholyte arm | Active comparator | Not described Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
| Crystal Lite | Active comparator | Not described Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
| Potassium Bicarbonate | Active comparator | Not described Receives: Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour urine volume
Total urine volume
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine volume
Total urine volume
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine creatinine
Urine creatinine
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine creatinine
Urine creatinine
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine calcium
urine calcium
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine calcium
urine calcium
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine potassium
Urine potassium
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine potassium
Urine potassium
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine sodium
Urine sodium
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine sodium
Urine sodium
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hours urine citrate
Urine citrate
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine citrate
Urine citrate
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hours urine uric acid
Urine uric acid
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine uric acid
Urine Uric Acid
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hours urine oxalate
Urine oxalate
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine oxalate
Urine oxalate
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hours urine magnesium
Urine magnesium
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine magnesium
Urine magnesium
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hours urine ammonia
Urine ammonia
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hours urine ammonia
Urine ammonia
Measured: Change from baseline (Day 4) to end of study (day 12)
24 Hour Urine pH
Overal Urine pH from 24h urine sample.
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 Hour Urine pH
Overal Urine pH from 24h urine sample.
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine phosphorus
Urine phosphorus
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine phosphorus
Urine phosphorus
Measured: Change from baseline (Day 4) to end of study (day 12)
24 hour urine sulfate
Urine sulfate
Measured: Change from baseline (Day 4) to initial start on treatment (Day 5)
24 hour urine sulfate
Urine sulfate
Measured: Change from baseline (Day 4) to end of study (day 12)
Secondary outcomes (4)
# of patient who adherence to 100% Medication
Patient's adherence to medication for duration of study.
Measured: At the end of study approximately 10 weeks after start of study.
Total out of pocket cost
Calculate and compare treatment costs for the different interventions (in American dollars).
Measured: At the end of study approximately 10 weeks after start of study.
Patient's Satisfaction Survey
Patient satisfaction survey, adapted from the Treatment Satisfaction Questionnaire for Medication-14. Patients are queried on their satisfaction, with 9 questions for each medication.
Measured: At the end of study approximately 10 weeks after start of study.
Patient's GI Distress
Patient's GI distress symptom scale measures patients GI distress. There are 18 questions with descriptive answers ranging from "none", "mild", "moderate", "quite a lot" and "unbearable". There are no numerical scores, rather just descriptive scores. "None" means no GI distress, "unbearable" means that you are in a lot of distress from your GI symptoms.
Measured: At the end of study approximately 10 weeks after start of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (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 StoneStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Johnson, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651088
- Sponsor's protocol ID
- STU-2020-0613
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scales 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 22498635Uribarri 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 2688503Pearle 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 24857648Pak CY, Sakhaee K, Fuller C. Successful management of uric acid nephrolithiasis with potassium citrate. Kidney Int. 1986 Sep;30(3):422-8. doi: 10.1038/ki.1986.201.
PubMed 3784284Ryall RL. Urinary inhibitors of calcium oxalate crystallization and their potential role in stone formation. World J Urol. 1997;15(3):155-64. doi: 10.1007/BF02201852. No abstract available.
PubMed 9228722Preminger GM, Sakhaee K, Skurla C, Pak CY. Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. J Urol. 1985 Jul;134(1):20-3. doi: 10.1016/s0022-5347(17)46963-1.
PubMed 4009822Ettinger 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 9366314Preminger GM, Sakhaee K, Pak CY. Alkali action on the urinary crystallization of calcium salts: contrasting responses to sodium citrate and potassium citrate. J Urol. 1988 Feb;139(2):240-2. doi: 10.1016/s0022-5347(17)42374-3.
PubMed 3339718Stern KL, Canvasser N, Borofsky M, Gleason VM, Kamphuis G, El Tayeb MM, Hsi R, Scotland KB. Alkalinizing Agents: A Review of Prescription, Over-the-Counter, and Medical Food Supplements. J Endourol. 2020 Jan;34(1):1-6. doi: 10.1089/end.2019.0292. Epub 2019 Sep 25.
PubMed 31333065
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multiple Alkalinizing Agents on Urinary Stone Risk Parameters in Stone and Non-stone Formers on a Metabolically Controlled Diet
- ClinicalTrials.gov ID
- NCT04651088
- Acronym / sponsor ID
- STU-2020-0613
- Conditions
- Kidney Stone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Dec 2020 (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.
The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
Detailed description
Kidney stones are a common medical problem, occurring in almost 10% of people in the United States1. Furthermore, 50% of patients will recur within 10 years2. Metabolic testing is advised in recurrent stone formers, as well as those considered high risk, to assess for a specific abnormality which may prompt intervention to prevent future stone formation. Non-surgical interventions include both dietary counselling, as well as pharmacotherapy.
One of the most commonly prescribed class of pharmacotherapies is alkali therapy which can be used to both increase the urinary pH and raise the urine citrate levels. This is particularly useful as correction of very acidic urinary pH (<5.5) can counteract uric acid crystallization thereby preventing or even dissolving uric acid stones3. Further, citrate has been shown to be a potent inhibitor of calcium stones by binding to the calcium directly4 and inhibiting crystal nucleation, thereby reducing calcium stone formation5,6.
The most commonly utilized preparation of alkali therapy is potassium citrate which has been shown to prevent stone formation better than sodium citrate7. Unfortunately, some forms of potassium citrate (crystal packets) have become unavailable, and the slow release form of potassium citrate (UroCit-K) now exceeds $15/day in cost8. There have been multiple alternative alkali therapies that have been used in place of potassium citrate, including both medical foods and prescription medications, but with little evidence to support their use. A pilot study in order to quantify the metabolic effects of these agents and compare them to potassium citrate will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Metabolic diet | Placebo comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium BicarbonateControlled metabolic diet arm. |
| Potassium citrate | Active comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium Bicarbonate |
| Sodium Bicarbonate | Active comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium Bicarbonate |
| Litholyte arm | Active comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium Bicarbonate |
| Crystal Lite | Active comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium Bicarbonate |
| Potassium Bicarbonate | Active comparator | Drug: Potassium citrate, Drug: Sodium bicarbonate, Dietary Supplement: Litholyte, Dietary Supplement: Crystal Lite, Drug: Potassium Bicarbonate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 and older.
- with or without a history of stone disease.
Key exclusion criteria (4 listed)
- They are unable to take any of the medications due to health reasons.
- Participants are pregnant or nursing.
- Participants are unable to adhere to the metabolic diet.
- Participants had a prior adverse event from one or more of the medications.
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 citrateSlow release potassium citrate UroCit-K. Participants will take 20mEq twice daily. | Drug | Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate |
| Sodium bicarbonate650mg tabs. Take 3 tabs twice daily. | Drug | Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate |
| LitholyteOne packet is taken with 170ml of water. Two packets daily. | Dietary supplement | Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate |
| Crystal LiteThe classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed. | Dietary supplement | Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate |
| Potassium Bicarbonate20 mEq tablets, one tablet twice daily | Drug | Crystal Lite, Litholyte arm, Metabolic diet, Potassium Bicarbonate, Potassium citrate, Sodium Bicarbonate |
Primary outcome
24 hour urine volume
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Total urine volume
24 hour urine volume
Time frame: Change from baseline (Day 4) to end of study (day 12)
Total urine volume
24 hour urine creatinine
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine creatinine
24 hour urine creatinine
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine creatinine
24 hour urine calcium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
urine calcium
24 hour urine calcium
Time frame: Change from baseline (Day 4) to end of study (day 12)
urine calcium
24 hour urine potassium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine potassium
24 hour urine potassium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine potassium
24 hour urine sodium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sodium
24 hours urine sodium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine sodium
24 hours urine citrate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine citrate
24 hours urine citrate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine citrate
24 hours urine uric acid
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine uric acid
24 hours urine uric acid
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine Uric Acid
24 hours urine oxalate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine oxalate
24 hours urine oxalate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine oxalate
24 hours urine magnesium
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine magnesium
24 hours urine magnesium
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine magnesium
24 hours urine ammonia
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine ammonia
24 hours urine ammonia
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine ammonia
24 Hour Urine pH
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Overal Urine pH from 24h urine sample.
24 Hour Urine pH
Time frame: Change from baseline (Day 4) to end of study (day 12)
Overal Urine pH from 24h urine sample.
24 hour urine phosphorus
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine phosphorus
24 hour urine phosphorus
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine phosphorus
24 hour urine sulfate
Time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)
Urine sulfate
24 hour urine sulfate
Time frame: Change from baseline (Day 4) to end of study (day 12)
Urine sulfate
4 secondary outcomes
# of patient who adherence to 100% Medication
Time frame: At the end of study approximately 10 weeks after start of study.
Total out of pocket cost
Time frame: At the end of study approximately 10 weeks after start of study.
Patient's Satisfaction Survey
Time frame: At the end of study approximately 10 weeks after start of study.
Patient's GI Distress
Time frame: At the end of study approximately 10 weeks after start of study.
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 13 Feb 2026.
- 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.
- 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 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 3784284Pak CY, Sakhaee K, Fuller C. Successful management of uric acid nephrolithiasis with potassium citrate. Kidney Int. 1986 Sep;30(3):422-8. doi: 10.1038/ki.1986.201.
- Background: PubMed 9228722Ryall RL. Urinary inhibitors of calcium oxalate crystallization and their potential role in stone formation. World J Urol. 1997;15(3):155-64. doi: 10.1007/BF02201852. No abstract available.
- Background: PubMed 4009822Preminger GM, Sakhaee K, Skurla C, Pak CY. Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. J Urol. 1985 Jul;134(1):20-3. doi: 10.1016/s0022-5347(17)46963-1.
- 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 3339718Preminger GM, Sakhaee K, Pak CY. Alkali action on the urinary crystallization of calcium salts: contrasting responses to sodium citrate and potassium citrate. J Urol. 1988 Feb;139(2):240-2. doi: 10.1016/s0022-5347(17)42374-3.
- Background: PubMed 31333065Stern KL, Canvasser N, Borofsky M, Gleason VM, Kamphuis G, El Tayeb MM, Hsi R, Scotland KB. Alkalinizing Agents: A Review of Prescription, Over-the-Counter, and Medical Food Supplements. J Endourol. 2020 Jan;34(1):1-6. doi: 10.1089/end.2019.0292. Epub 2019 Sep 25.
- Individual participant dataSharing planned: No
Related trials for Kidney Stone
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
Recruiting
Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology
Urolithiasis, Stones, Kidney
Active, not recruitingObservational study
A Retrospective, Multi-center Real-world Study of Steerable Ureteroscopic Renal Evacuation (SURE) Procedure With the CVAC® System
Urolithiasis, Kidney Stone
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
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.
Ashley Gonzalez, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Potassium citrate, Sodium bicarbonate and Litholyte in people with Kidney Stone, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 2 inclusion and 4 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 13 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 1 site in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Brett A Johnson, MD (214-648-6853, brett.johnson@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour urine volume (time frame: Change from baseline (Day 4) to initial start on treatment (Day 5)). The study lists 26 primary outcomes in all. 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 NCT04651088, 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 13 Feb 2026.