What side effects are associated with this type of intervention?

Common treatments for kidney stones include dietary modifications and pharmacologic agents. Dietary changes, such as reducing intake of oxalate-rich foods, can lead to nutritional imbalances if not properly managed. Pharmacologic treatments like thiazide diuretics may cause side effects such as electrolyte imbalances, dehydration, and increased blood sugar levels. Potassium citrate can lead to gastrointestinal discomfort, including nausea and diarrhea. Allopurinol, used to lower uric acid levels, may cause skin rashes and, rarely, severe hypersensitivity reactions. Patients should discuss these potential side effects with their healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several pharmacologic agents for the treatment of kidney stones, focusing on altering urine composition to prevent stone formation. These include thiazide diuretics, which reduce calcium excretion in urine, and potassium citrate, which alkalinizes urine to prevent the formation of uric acid and cystine stones. Additionally, allopurinol is used to lower uric acid levels in patients with hyperuricosuria. Dietary modifications, such as reducing sodium and animal protein intake, are also recommended to decrease the risk of stone formation. These treatments align with the strategies being studied in the trial of selective and empiric diet plus pharmacologic therapy.

What other types of research exist?

Promising novel alternatives for kidney stone treatment in 2024 include: 1) Genetic and molecular therapies targeting specific pathways involved in stone formation, 2) Advanced minimally invasive surgical techniques such as improved laser lithotripsy, 3) Use of nanotechnology for targeted drug delivery to dissolve stones, and 4) Development of new pharmacologic agents that more effectively alter urine composition or inhibit stone formation at the molecular level.

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Dietary Modification

Prevention Strategies for Kidney Stones

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

The most common treatments for kidney stones involve dietary modifications and pharmacologic agents. Dietary modifications aim to reduce the intake of stone-forming substances like oxalates, purines, and sodium, while increasing fluid intake to dilute urine. Pharmacologic agents work by altering urine composition to prevent stone formation. Thiazide diuretics reduce calcium excretion, potassium citrate alkalinizes urine to prevent uric acid and cystine stones, and allopurinol reduces uric acid production. These mechanisms are crucial for kidney stone patients as they help in creating effective, individualized treatment plans to prevent recurrence and manage existing stones.

Phase 4

Recruiting

Led By Ryan Hsi, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Two or more symptomatic kidney stone events in the last 5 years

Be older than 18 years old

Must not have

Chronic kidney disease stage 3 or higher (eGFR<60)

Untreated urinary obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline compared to two months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial compares two methods to prevent kidney stones in patients who have had multiple episodes. One method uses specific urine tests to guide treatment, while the other uses a general treatment approach. Both methods involve diet changes and medications to reduce stone-forming substances in the urine. Recognized medications for preventing kidney stone recurrence include thiazide diuretics, allopurinol, and potassium citrate.

Who is the study for?

This trial is for adults who've had two or more painful kidney stone episodes in the past five years. It's not suitable for those with certain kidney conditions, untreated urinary blockages, specific metabolic disorders, pregnancy, inflammatory bowel disease or related surgeries, sarcoidosis, cystinuria, severe chronic kidney disease (eGFR<60), frequent gout attacks, allergies to study meds or imbalances in blood potassium/sodium.

What is being tested?

The study compares two approaches to prevent new kidney stones: 'Selective Therapy' which tailors diet and drugs to individual needs versus 'Empiric Therapy' that uses a general diet and medication plan. Participants are randomly assigned to one of these strategies.

What are the potential side effects?

Potential side effects from the treatments could include digestive issues due to dietary changes and reactions like rashes or other symptoms from medications. Adherence difficulty and any organ-specific impacts will also be monitored as adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had two or more painful kidney stone episodes in the past 5 years.

Exclusion Criteria

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

Select...

My kidney function is reduced (eGFR<60).

Select...

I have a blockage in my urinary system that hasn't been treated.

Select...

I am taking medication like thiazides or topiramate.

Select...

I have inflammatory bowel disease or have had part of my bowel removed.

Select...

I am under 18 years old.

Select...

I have been diagnosed with primary hyperoxaluria.

Select...

I have gout or had 3 gout attacks in the last year.

Select...

I have been diagnosed with medullary sponge kidney or renal tubular acidosis.

Select...

I have been diagnosed with primary hyperparathyroidism.

Select...

I have been diagnosed with sarcoidosis.

Select...

I have been diagnosed with cystinuria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Calcium oxalate supersaturation

Calcium phosphate supersaturation

Secondary study objectives

24hr urine parameters

Uric acid supersaturation

Other study objectives

24hr urine parameters from baseline to month 1

24hr urine parameters from month 1 to month 2

Adverse events

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Selective TherapyExperimental Treatment2 Interventions

Diet intervention and drug intervention based on 24 hour urine results

Group II: Empiric TherapyActive Control2 Interventions

Diet intervention and drug intervention not based on 24 hour urine results

0 / 12Eligibility 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

The most common treatments for kidney stones involve dietary modifications and pharmacologic agents. Dietary modifications aim to reduce the intake of stone-forming substances like oxalates, purines, and sodium, while increasing fluid intake to dilute urine. Pharmacologic agents work by altering urine composition to prevent stone formation. Thiazide diuretics reduce calcium excretion, potassium citrate alkalinizes urine to prevent uric acid and cystine stones, and allopurinol reduces uric acid production. These mechanisms are crucial for kidney stone patients as they help in creating effective, individualized treatment plans to prevent recurrence and manage existing stones.