Status:
WITHDRAWN
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Acute Interstitial Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01893658
Start Date
June 1 2018
End Date
September 28 2018
Last Update
December 6 2018
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905