Clinical Trial: Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Brief Summary: To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome:

  • Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) [ Time Frame: From the beginning to the end of the study ]
  • Development of proteinuria [ Time Frame: From the beginning to the end of the study ]
  • 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation [ Time Frame: From the beginning to the end of the study ]
  • body weight, blood pressure, pulse [ Time Frame: From the beginning to the end of the study ]
  • Adverse effects of treatment [ Time Frame: From the beginning to the end of the study ]


Original Primary Outcome:

  • Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
  • Development of proteinuria
  • 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: February 20, 2007
Date Started: July 2004
Date Completion:
Last Updated: November 17, 2010
Last Verified: November 2010