Clinical Trial: Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Effect of Intensive Urate Lowering Therapy (ULT) With Febuxostat in Comparison With Allopurinol on Cardiovascular Risk in Patients With Gout Using Surrogate Markers: a Randomized, Controlled Trial

Brief Summary: Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.

Detailed Summary:
Sponsor: Menarini International Operations Luxembourg SA

Current Primary Outcome: Pulse Wave Velocity [ Time Frame: 36 weeks of treatment ]

Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Brain natriuretic peptide (BNP) and NTproBNP values [ Time Frame: 12, 24 and 36 weeks of treatment ]
  • Changes in inflammation markers [ Time Frame: 12, 24 and 36 weeks of treatment ]
  • Changes in oxidative stress parameters [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in lipid profile [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Percentage of gout patients with a serum Urate acid (sUA) concentration of less than 6 mg/dl [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Time to achieve sUA target levels for patients stratified for sUA levels at baseline as follows: 8.1-8.8 mg/dl, 8.9-9.6 mg/dl, 9.7-10.3 mg/dl, 10.4-11.00 mg/dl, >11 mg/dl [ Time Frame: 36 weeks ]
  • Changes in Estimated Glomerular Filtration Rate (eGFR) with Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in urine albumin excretion as evaluated by first morning urine albumin/creatinine ratio (mg/g) [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Percentage of patients above the sUA target levels [ Time Frame: 12,24 and 36 weeks of treatment after having reached the sUA target levels at week 2 ]
  • Tender and swollen joint count [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Pulse Wave Analysis [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in endothelial activation/adhesion markers [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: 36 weeks of treatment ]


Original Secondary Outcome:

  • Changes in BNP and NTproBNP values [ Time Frame: 12, 24 and 36 weeks of treatment ]
  • Changes in inflammation markers [ Time Frame: 12, 24 and 36 weeks of treatment ]
  • Changes in oxidative stress parameters [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in lipid profile [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Percentage of gout patients with a serum Urate concentration of less than 6 mg/dl [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Time to achieve sUA target levels for patients stratified for sUA levels at baseline as follows: 8.1-8.8 mg/dl, 8.9-9.6 mg/dl, 9.7-10.3 mg/dl, 10.4-11.00 mg/dl, >11 mg/dl [ Time Frame: 36 weeks ]
  • Changes in eGFR with Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in urine albumin excretion as evaluated by first morning urine albumin/creatinine ratio (mg/g) [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Percentage of patients above the sUA target levels [ Time Frame: 12,24 and 36 weeks of treatment after having reached the sUA target levels at week 2 ]
  • Tender and swollen joint count [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Pulse Wave Analysis [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Changes in endothelial activation/adhesion markers [ Time Frame: 12,24 and 36 weeks of treatment ]
  • Number of participants with adverse events as a measure of Safety and Tolerability [ Time Frame: 36 weeks of treatment ]


Information By: Menarini International Operations Luxembourg SA

Dates:
Date Received: July 7, 2015
Date Started: July 2015
Date Completion: May 2017
Last Updated: March 21, 2017
Last Verified: March 2017