Clinical Trials Logo
  1. Home
  2. Kidney Stones
  3. NCT01077284

Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones

Kidney Stones Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo and Allopurinol Controlled, Phase 2 Study to Evaluate Febuxostat in the Medical Management of Subjects With Hyperuricosuria and Calcium Oxalate Stones

Clinical Trial Summary

The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.

Clinical Trial Description

Nephrolithiasis, also called kidney stone disease, occurs in patients with genetic susceptibility and who may have a broad spectrum of metabolic disorders and other comorbid conditions (for example obesity or diabetes). These renal stones develop as a result of supersaturation. Calcium oxalate (CaOx) is the most common type of stone. Reducing the urinary excretion of uric acid is an established approach for the treatment of CaOx kidney stones.

The objective of this study is to evaluate treatment with febuxostat compared to allopurinol or placebo in the reduction of 24-hour urine uric acid (uUA) excretion levels in hyperuricosuric patients with a recent history of renal stones and the presence of at least one CaOx stone larger than or equal to 3 mm as seen on Multidetector Computed Tomographic Angiography (MDCT).

Participants in this study will be required to make 4 office visits provide 3 urine samples and undergo 2 MDCT scans (a type of x-ray) of their kidneys. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01077284
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date February 2010
Completion date November 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT02547805 - Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days Phase 2
Completed NCT02579161 - Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy Phase 3
Completed NCT01187745 - Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones N/A
Withdrawn NCT00875823 - International Registry for Primary Hyperoxaluria N/A
Completed NCT05519150 - Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Recruiting NCT02522689 - Comparison of Ultra-mini PCNL and Micro PCNL N/A
Recruiting NCT01514032 - Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones N/A
Completed NCT00873054 - Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy N/A
Completed NCT00765128 - Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy Phase 4
Withdrawn NCT00583258 - A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones N/A
Active, not recruiting NCT03630926 - Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Completed NCT03095885 - A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria N/A
Completed NCT01088555 - Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers N/A
Completed NCT01330940 - Effect of Diet Orange Soda on Urinary Lithogenicity N/A
Recruiting NCT00489723 - Is There is a Role of Prophylactic Therapy With Tamsulosin Before Extracorporeal Shock Wave Lithotripsy to Avoid Development of Steinstrasse ? N/A
Recruiting NCT05417568 - Oxalate-Driven Host Responses in Kidney Stone Disease N/A
Recruiting NCT02375295 - Struvite Stones Antibiotic Study Phase 4
Enrolling by invitation NCT02408211 - Preoperative Antibiotic PNL Study Phase 4
Withdrawn NCT01560091 - Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy Phase 3