Clinical trial NCT01893658: Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Official title: Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Interstitial Nephritis
Keywords: Interstitial Nephritis
Nephritis
Tubulointerstitial
Renal disease
Kidney
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2013-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Adult subjects \> 18 years old of both genders
2. Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy
3. Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy
4. 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)
5. No immunosuppressants in the last three months including prednisone
6. 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:

1. Unwillingness to give consent
2. Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding
3. Documented history of an autoimmune disease
4. Inability or unwillingness to take prednisone for the prescribed duration and/or dose
5. Subjects suspected to have non-drug-induced AIN
6. Subjects not meeting the inclusion criteria
7. Subjects with contraindication to administration of omalizumab
8. Prior use of omalizumab
9. Severe hypersensitivity to omalizumab or any component of the product
10. Known elevated IgE level from other disease processes
11. Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically
12. Use of any other investigational agents in the last 30 days
13. 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.

Primary outcomes:
measure: Change in serum creatinine
timeFrame: Baseline to three months
Secondary outcomes:
measure: Mean individual percentage drop in serum creatinine relative to entry creatinine levels
timeFrame: baseline to 3 months
measure: Percentage of subjects returning to their usual baseline creatinine (+25%) or below
timeFrame: baseline to 3 months
measure: Reduction in Neutrophil gelatinase-associated lipocalcin.
timeFrame: baseline to 3 months
measure: Percentage of subjects requiring renal replacement therapy
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vesna D. Garovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References: