Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

Withdrawn before enrolling · Phase 2

Conditions studied: Acute Interstitial Nephritis

In brief

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.

Key facts

Study ID

NCT01893658

Run by

Mayo Clinic

People needed

0

Starts

2018-06-01

Expected to finish

2018-09-28

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Subjects not meeting the inclusion criteria
• Subjects with contraindication to administration of omalizumab
• Prior use of omalizumab
• Severe hypersensitivity to omalizumab or any component of the product
• Known elevated IgE level from other disease processes
• Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically
• Use of any other investigational agents in the last 30 days
• Patients with severe medical condition(s) including metastatic cancer, terminal congestive heart failure, severe ischemic heart disease or any other medical condition in which life expectancy is less than 6 months.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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