Acute Interstitial Nephritis
Conditions
Keywords
Interstitial Nephritis, Nephritis, Tubulointerstitial, Renal disease, Kidney
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.
Interventions
DRUGOmalizumab
administration of a single dose together with the standard treatment
DRUGPrednisone
standard treatment
Sponsors
Genentech, Inc.
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum creatinine | Baseline to three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean individual percentage drop in serum creatinine relative to entry creatinine levels | baseline to 3 months | — |
| Percentage of subjects returning to their usual baseline creatinine (+25%) or below | baseline to 3 months | — |
| Reduction in Neutrophil gelatinase-associated lipocalcin. | baseline to 3 months | 24 hours, 4 hours, and in 3 months after Xolair treatment |
| Percentage of subjects requiring renal replacement therapy | baseline to 3 months | — |
Countries
United States
Outcome results
None listed