Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04370093 · ClinicalTrials.gov registry record · Phase 4
Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT04370093: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT04370093 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04370093, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
The investigators will randomize overweight and obese iuan patients to Pio (45 mg/day, highest approved dose or placebo), WL (10% of body weight, following the established program used in the Diabetes Prevention Program), or Pio+WL. Participants will be evaluated at baseline and after 24 weeks of intervention while on a fixed metabolic diet to exclude the confounding effects of diet and perspiration. The primary endpoint will be change in upH, and multiple additional endpoints (serum, urine, imaging) will be assessed.
Primary Outcome
24-hour urine pH is the main determinant of uric acid stone formation and recurrence. There is no universally accepted clinical scale for Δ (delta) urine pH like there is for some other biomarkers. In research, Δ urine pH is simply: Δ urine pH = Post-intervention urine pH - Baseline urine pH A practical interpretation commonly used in renal physiology and stone research is: Δ Urine pH Interpretation \< 0 Urine became more acidic 0 to +0.2 No meaningful change * 0.2 to +0.5 Mild alkalinizati
Interventions
- DRUG Pioglitazone 45 mg
- BEHAVIORAL Weight Loss
- OTHER Pioglitazone + Weight Loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2025-05-28 |
| Phase | Phase 4 |
What the finished NCT04370093 record still lists
NCT04370093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Pioglitazone 45 mg is the first listed.
NCT04370093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04370093 about?
NCT04370093 is a clinical study titled "Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss". The investigators will randomize overweight and obese iuan patients to Pio (45 mg/day, highest approved dose or placebo), WL (10% of body weight, following the established program used in the Diabetes Prevention Program), or Pio+WL. Participants will be evaluated at baseline and after 24 weeks of in...
What is the current status of trial NCT04370093?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2019-10-17. Estimated completion is 2025-05-28.
What interventions are being tested in trial NCT04370093?
The interventions under investigation include: Pioglitazone 45 mg (DRUG), Weight Loss (BEHAVIORAL), Pioglitazone + Weight Loss (OTHER).
Who is sponsoring clinical trial NCT04370093?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04370093's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI