Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN) (NCT01893658) | Clinical Trial Compass
WithdrawnPhase 2
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Stopped: Lack of patients with a condition of interest that resulted in failure to recruit
United States0Started 2018-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult subjects \> 18 years old of both genders
✓. Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy
✓. Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy
✓. Serum creatinine elevation of \> 0.3 mg/dL and/or doubling of serum creatinine compared to most recent documented creatinine available (at least within the last year)
✓. No immunosuppressants in the last three months including prednisone
✓. Women of childbearing potential not using the contraception method can be included as this is a one time dosing and has no known long-term effects.
Exclusion criteria
✕. Unwillingness to give consent
✕. Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding
✕. Documented history of an autoimmune disease
✕. Inability or unwillingness to take prednisone for the prescribed duration and/or dose
✕. Subjects suspected to have non-drug-induced AIN