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Dietary Supplement

Hydroxycitrate for Kidney Stones

Phase 4
Recruiting
Led By NAIM M MAALOUF
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Calcium Phosphate stone formers
Be older than 18 years old
Must not have
History of recurrent urinary tract infections
Chronic diarrhea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 week of treatment
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests whether hydroxycitrate can reduce the recurrence of kidney stones in patients who frequently get them. It compares hydroxycitrate to potassium citrate. The treatment works by preventing the formation of crystals that cause kidney stones. Hydroxycitrate is a derivative of citric acid and has shown the ability to inhibit the formation of calcium oxalate crystals in vitro.

Who is the study for?
This trial is for people who form calcium phosphate kidney stones. It's not suitable for pregnant individuals, those with low potassium levels, frequent urinary infections, chronic diarrhea, poor kidney function (eGFR < 45), or a history of overactive parathyroid glands.
What is being tested?
The study is testing hydroxycitrate (OHCit) in two different doses to see if it can prevent new kidney stones from forming. Participants will also receive either Potassium Citrate or a placebo as part of the treatment comparison.
What are the potential side effects?
Possible side effects may include gastrointestinal discomfort such as upset stomach or diarrhea and changes in blood potassium levels which could affect heart rhythm and muscle function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I form calcium phosphate kidney stones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had multiple urinary tract infections.
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I have chronic diarrhea.
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I have been diagnosed with primary hyperparathyroidism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 1 week of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1 week of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Formation product (FP) for Calcium Phosphate
Secondary study objectives
Calcium Phosphate supersaturation
Crystal growth of Calcium Phosphate

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Super CitriMax; OHCit-standard doseExperimental Treatment1 Intervention
Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
Group II: Super CitriMax; OHCit-low doseExperimental Treatment1 Intervention
Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d
Group III: Potassium Citrate (Urocit®-K)Active Control1 Intervention
Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d
Group IV: PlaceboPlacebo Group1 Intervention
Placebo 3 tablets twice daily Total Daily Dose: None

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for kidney stones often work by inhibiting stone formation through various mechanisms. Hydroxycitrate, for instance, binds to calcium, preventing it from combining with oxalate or phosphate to form stones. Similarly, potassium citrate increases urinary citrate levels, which binds to calcium and reduces stone formation. Thiazide diuretics decrease calcium excretion in urine, lowering the risk of stone formation. These mechanisms are important for kidney stone patients as they help in selecting treatments that target specific pathways involved in stone formation, thereby reducing recurrence and improving patient outcomes.
Hypercalciuria associated with high dietary protein intake is not due to acid load.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,139 Total Patients Enrolled
NAIM M MAALOUFPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
~17 spots leftby May 2028
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