Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet

NCT04651088 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STU-2020-0613
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone

Outcome Measures

Primary Outcomes (26)

• 24 hour urine volume

  Total urine volume

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine volume

  Total urine volume

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine creatinine

  Urine creatinine

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine creatinine

  Urine creatinine

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine calcium

  urine calcium

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine calcium

  urine calcium

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine potassium

  Urine potassium

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine potassium

  Urine potassium

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine sodium

  Urine sodium

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine sodium

  Urine sodium

  Change from baseline (Day 4) to end of study (day 12)

• 24 hours urine citrate

  Urine citrate

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine citrate

  Urine citrate

  Change from baseline (Day 4) to end of study (day 12)

• 24 hours urine uric acid

  Urine uric acid

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine uric acid

  Urine Uric Acid

  Change from baseline (Day 4) to end of study (day 12)

• 24 hours urine oxalate

  Urine oxalate

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine oxalate

  Urine oxalate

  Change from baseline (Day 4) to end of study (day 12)

• 24 hours urine magnesium

  Urine magnesium

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine magnesium

  Urine magnesium

  Change from baseline (Day 4) to end of study (day 12)

• 24 hours urine ammonia

  Urine ammonia

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hours urine ammonia

  Urine ammonia

  Change from baseline (Day 4) to end of study (day 12)

• 24 Hour Urine pH

  Overal Urine pH from 24h urine sample.

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 Hour Urine pH

  Overal Urine pH from 24h urine sample.

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine phosphorus

  Urine phosphorus

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine phosphorus

  Urine phosphorus

  Change from baseline (Day 4) to end of study (day 12)

• 24 hour urine sulfate

  Urine sulfate

  Change from baseline (Day 4) to initial start on treatment (Day 5)

• 24 hour urine sulfate

  Urine sulfate

  Change from baseline (Day 4) to end of study (day 12)

Secondary Outcomes (4)

• # of patient who adherence to 100% Medication

  At the end of study approximately 10 weeks after start of study.

• Total out of pocket cost

  At the end of study approximately 10 weeks after start of study.

• Patient's Satisfaction Survey

  At the end of study approximately 10 weeks after start of study.

• Patient's GI Distress

  At the end of study approximately 10 weeks after start of study.

Study Arms (6)

Metabolic diet

PLACEBO COMPARATOR

Controlled metabolic diet arm.

Drug: Potassium citrate; Drug: Sodium bicarbonate; Dietary Supplement: Litholyte; Dietary Supplement: Crystal Lite; Drug: Potassium Bicarbonate

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

Interventions

Potassium citrate DRUG

Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.

Crystal Lite; Litholyte arm; Metabolic diet; Potassium Bicarbonate; Potassium citrate; Sodium Bicarbonate

Sodium bicarbonate DRUG

650mg tabs. Take 3 tabs twice daily.

Crystal Lite; Litholyte arm; Metabolic diet; Potassium Bicarbonate; Potassium citrate; Sodium Bicarbonate

Litholyte DIETARY_SUPPLEMENT

One packet is taken with 170ml of water. Two packets daily.

Crystal Lite; Litholyte arm; Metabolic diet; Potassium Bicarbonate; Potassium citrate; Sodium Bicarbonate

Crystal Lite DIETARY_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.

Crystal Lite; Litholyte arm; Metabolic diet; Potassium Bicarbonate; Potassium citrate; Sodium Bicarbonate

Potassium Bicarbonate DRUG

20 mEq tablets, one tablet twice daily

Crystal Lite; Litholyte arm; Metabolic diet; Potassium Bicarbonate; Potassium citrate; Sodium Bicarbonate

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and older.
• with or without a history of stone disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (9)

• 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.

  PMID: 22498635 BACKGROUND

• Uribarri 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.

  PMID: 2688503 BACKGROUND

• Pearle 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.

  PMID: 24857648 BACKGROUND

• Pak 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.

  PMID: 3784284 BACKGROUND

• Ryall 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.

  PMID: 9228722 BACKGROUND

• Preminger 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.

  PMID: 4009822 BACKGROUND

• Ettinger 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.

  PMID: 9366314 BACKGROUND

• Preminger 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.

  PMID: 3339718 BACKGROUND

• Stern 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.

  PMID: 31333065 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Interventions

Potassium Citrate; Sodium Bicarbonate; potassium bicarbonate

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Brett A Johnson, MD

CONTACT

214-648-6853; brett.johnson@utsouthwestern.edu

Ashley Gonzalez, MD

CONTACT

ashley.gonzalez2@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 3, 2020
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)