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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

IUAN Trial 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.Check my eligibility
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.See study design
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.

IUAN Trial Eligibility Criteria

Inclusion Criteria

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

IUAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reversal of renal lipotoxicity will occur with pioglitazone.

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

IUAN 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
57 Previous Clinical Trials
8,903 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,181 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center - Center for Mineral Metabolism
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pathophysiology of Uric Acid Nephrolithiasis
Khashayar Sakhaee 2019. "Pathophysiology of Uric Acid Nephrolithiasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00904046.
All > Kidney Stone > Texas
~7 spots leftby Nov 2024
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