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Thiazolidinedione

Pioglitazone for Kidney Stones (IUAN Trial)

N/A
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
Subjects with uric acid kidney stone disease
Age > 21 years
Must not have
Chronic liver disease
Chronic renal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will study whether pioglitazone can help prevent kidney stones by reducing the amount of fat in kidney cells.

Who is the study for?
This trial is for adults over 21 with uric acid kidney stones. It's not suitable for those over 350 lb, with chronic alcohol use, liver or renal disease, anemia, heart failure (NYHA class III/IV), significant pedal edema, liver failure, or recent thiazolidinedione use. Participants must agree to effective contraception.
What is being tested?
The study tests if Pioglitazone reduces fatty acids in kidneys and helps prevent uric acid stone formation compared to a placebo. Pioglitazone is FDA-approved for diabetes but not yet for kidney stone risk reduction.
What are the potential side effects?
Pioglitazone may cause fluid retention leading to swelling and weight gain; it can also increase the risk of heart problems and bladder cancer in long-term use. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have kidney stones made of uric acid.
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I am older than 21 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a long-term liver condition.
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I have long-term kidney disease.
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I have anemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01612858
19%
diarrhea
13%
Elevated lactic acid
13%
nausea
13%
Elevated serum creatinine
6%
Bloating
6%
Head trauma accompanied by syncope
6%
vomiting
6%
Baker's cyst
6%
tooth pain
6%
Right upper quadrant abdominal pain
6%
Colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin
Pioglitazone

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PioglitazoneExperimental Treatment1 Intervention
For 60 Aim 2 Subjects Only - Pioglitazone (Actos)
Group II: PlaceboPlacebo Group1 Intervention
For 60 Subjects in Aim 2 Only - Placebo for Pioglitazone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone
2005
Completed Phase 4
~27720

Find a Location

Who is running the clinical trial?

Takeda Pharmaceuticals North America, Inc.Industry Sponsor
58 Previous Clinical Trials
108,903 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,104 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,764 Total Patients Enrolled

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT00904046 — N/A
Kidney Stone Disease Research Study Groups: Pioglitazone, Placebo
Kidney Stone Disease Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT00904046 — N/A
Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00904046 — N/A
~1 spots leftby Nov 2024
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