What side effects are associated with this type of intervention?

Common treatments for kidney stones that inhibit stone formation by binding to calcium include citrate supplements (such as potassium citrate) and hydroxycitrate. The known side effects of citrate supplements can include gastrointestinal discomfort, such as nausea, vomiting, and diarrhea. In some cases, they may also cause hyperkalemia (elevated potassium levels) if not monitored properly. Hydroxycitrate, being closely related to citrate, may have similar side effects, although specific data on its side effects are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney stones, primarily focusing on medications that alter urine composition to prevent stone formation. Citrate supplements, such as potassium citrate, are commonly used to bind calcium and inhibit stone formation. Additionally, thiazide diuretics are prescribed to reduce calcium excretion in urine. While hydroxycitrate is being studied for its potential to inhibit stone formation by binding to calcium, it is not yet FDA-approved. Current treatments aim to manage and prevent stones through dietary modifications, increased fluid intake, and medications that alter urinary chemistry.

What other types of research exist?

Promising novel alternatives to Hydroxycitrate for kidney stone treatment in 2024 include: 1) Thiazide diuretics, which reduce calcium excretion in urine, 2) Potassium citrate, which alkalinizes urine and binds to calcium, preventing stone formation, and 3) Allopurinol, which reduces uric acid production and is particularly effective for uric acid stones. These treatments target different aspects of stone formation and can be considered based on the specific type of kidney stones and patient profile.

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Dietary Supplement

Hydroxycitrate for Kidney Stones

Q: What is the mechanism of action of this treatment?

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.

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

Select...

I form calcium phosphate kidney stones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had multiple urinary tract infections.

Select...

I have chronic diarrhea.

Select...

I have been diagnosed with primary hyperparathyroidism.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1 week of treatment

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

0 / 4Eligibility criteria met

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.