What side effects are associated with this type of intervention?

Common treatments for kidney stones, such as Pioglitazone (a PPARγ agonist) and weight loss interventions, have specific side effects. Pioglitazone can cause weight gain, edema, and an increased risk of fractures. Weight loss interventions, involving caloric restriction and increased physical activity, may lead to nutritional deficiencies, muscle loss, and cardiovascular stress if not properly managed.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney stones, primarily focusing on medications that manage pain, facilitate stone passage, or prevent stone formation. Commonly approved drugs include thiazide diuretics, which reduce calcium in the urine, and potassium citrate, which helps prevent stone formation. While Pioglitazone (a PPARγ agonist) and weight loss strategies are being studied for their potential benefits in kidney stone management, they are not yet FDA-approved for this specific indication. Current treatments do not typically involve PPARγ agonists or structured weight loss programs.

What other types of research exist?

Promising novel alternatives for kidney stone patients include Sodium-glucose cotransporter 2 inhibitors (SGLT2Is), which may reduce nephrolithiasis risk by increasing urine flow. Additionally, urolithins, particularly urolithin A, derived from ellagitannin-rich foods, have shown nephroprotective properties and potential therapeutic benefits in preclinical studies.

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Thiazolidinedione

Pioglitazone + Weight Loss for Kidney Stones

Phase 4

Recruiting

Led By Khashayar Sakhaee, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests the effects of Pioglitazone, weight loss, or both in overweight and obese patients with uric acid kidney stones. Pioglitazone helps the body use insulin better and reduces urine acid, while weight loss improves health and reduces the risk of stones.

Who is the study for?

This trial is for adults over 21 with a specific type of kidney stone (over 90% uric acid) who are overweight but weigh less than 165 kg. They should have normal kidney function and not be on certain medications or have conditions like chronic diarrhea, heart failure, or uncontrolled diabetes.

What is being tested?

The study tests the effects of Pioglitazone (a diabetes drug), weight loss, or both combined on patients with uric acid kidney stones. Participants will follow a fixed diet and be monitored through various medical assessments over a period of 24 weeks.

What are the potential side effects?

Pioglitazone may cause side effects such as liver issues, swelling in legs (pedal edema), heart failure symptoms worsening if pre-existing, and potential increased risk of bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Urine pH

Secondary study objectives

Uric acid

Urine Ammonium/Net Acid Excretion

Urine Net Acid Excretion/Sulphate

Awards & Highlights

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.

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Weight Loss, BehavioralExperimental Treatment1 Intervention

Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Group II: Pioglitazone Drug (including Placebo)Experimental Treatment1 Intervention

45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study

Group III: Pioglitazone + Weight LossExperimental Treatment1 Intervention

Pioglitazone 45 mg/day + Weight Loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Weight Loss

2008

Completed Phase 3

~1570

Pioglitazone 45 mg

2000

Completed Phase 4

~960

Do I qualify?Apply below to find out

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

Pioglitazone, a PPARγ agonist, reduces overly acidic urine, thereby lowering the risk of uric acid stone formation. Weight loss through caloric restriction and increased physical activity improves metabolic health, reduces urinary calcium and oxalate excretion, and increases urinary citrate excretion. These treatments are important for kidney stone patients as they target the metabolic and urinary abnormalities that lead to stone formation, thereby reducing the risk and recurrence of kidney stones.

The impact of body mass index on quantitative 24-h urine chemistries in stone forming patients: a systematic review and meta-analysis.Increased production and reduced urinary buffering of acid in uric acid stone formers is ameliorated by pioglitazone.Weight loss intervention reduces the risk of kidney stone formation in a rat model of metabolic syndrome.