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

Acute Interstitial Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01893658
• Other study ID #: 12-006797
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: December 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Interstitial Nephritis
• Nephritis
• Nephritis, Interstitial

Intervention

Drug:
• Omalizumab
administration of a single dose together with the standard treatment
• Prednisone
standard treatment

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum creatinine		Baseline to three months
Secondary	Mean individual percentage drop in serum creatinine relative to entry creatinine levels		baseline to 3 months
Secondary	Percentage of subjects returning to their usual baseline creatinine (+25%) or below		baseline to 3 months
Secondary	Reduction in Neutrophil gelatinase-associated lipocalcin.	24 hours, 4 hours, and in 3 months after Xolair treatment	baseline to 3 months
Secondary	Percentage of subjects requiring renal replacement therapy		baseline to 3 months