Clinical Trial: Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Brief Summary: The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of prednisone for treatment of drug-induced AIN. Currently there is no good treatment for drug-induced AIN. Prednisone is the standard treatment but is associated with many side-effects when used long-term and at high doses.
Detailed Summary:
Sponsor: Mayo Clinic
Current Primary Outcome: Change in serum creatinine [ Time Frame: Baseline to three months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean individual percentage drop in serum creatinine relative to entry creatinine levels [ Time Frame: baseline to 3 months ]
- Percentage of subjects returning to their usual baseline creatinine (+25%) or below [ Time Frame: baseline to 3 months ]
- Reduction in Neutrophil gelatinase-associated lipocalcin. [ Time Frame: baseline to 3 months ]24 hours, 4 hours, and in 3 months after Xolair treatment
- Percentage of subjects requiring renal replacement therapy [ Time Frame: baseline to 3 months ]
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: June 12, 2013
Date Started: June 2013
Date Completion: May 2017
Last Updated: June 16, 2016
Last Verified: May 2016
