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

Phase 2

Withdrawn

• Conditions: Acute Interstitial Nephritis
• Interventions: Drug: Omalizumab; Drug: Prednisone

• Registration Number: NCT01893658
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Study Start: 2018-06-01
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omalizumab and Prednisone	Prednisone	Omalizumab in addition to prednisone. Omalizumab will be given once subcutaneously at a dose of 375 mg within 24 hours after receiving prednisone Standard clinical therapy with prednisone. * Day 1-14: 60 mg/day 14 days (2 weeks) * Day 15-28: 40 mg/day (2 weeks) * Day 29-35: 30 mg/day (1 week) * Day 36-42: 20 mg/day (1 week) * Day 43-49: 10 mg/day (1 week) * Day 50-56: 5 mg/day (1 week) * Subjects will stop taking prednisone on day 57 If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).
Omalizumab and Prednisone	Omalizumab	Omalizumab in addition to prednisone. Omalizumab will be given once subcutaneously at a dose of 375 mg within 24 hours after receiving prednisone Standard clinical therapy with prednisone. * Day 1-14: 60 mg/day 14 days (2 weeks) * Day 15-28: 40 mg/day (2 weeks) * Day 29-35: 30 mg/day (1 week) * Day 36-42: 20 mg/day (1 week) * Day 43-49: 10 mg/day (1 week) * Day 50-56: 5 mg/day (1 week) * Subjects will stop taking prednisone on day 57 If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).
Prednisone	Prednisone	Standard clinical therapy with prednisone. * Day 1-14: 60 mg/day 14 days (2 weeks) * Day 15-28: 40 mg/day (2 weeks) * Day 29-35: 30 mg/day (1 week) * Day 36-42: 20 mg/day (1 week) * Day 43-49: 10 mg/day (1 week) * Day 50-56: 5 mg/day (1 week) * Subjects will stop taking prednisone on day 57 If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose).

Primary Outcome Measures

Name	Time	Method
Change in serum creatinine	Baseline to three months

Secondary Outcome Measures

Name	Time	Method
Reduction in Neutrophil gelatinase-associated lipocalcin.	baseline to 3 months	24 hours, 4 hours, and in 3 months after Xolair treatment
Percentage of subjects returning to their usual baseline creatinine (+25%) or below	baseline to 3 months
Mean individual percentage drop in serum creatinine relative to entry creatinine levels	baseline to 3 months
Percentage of subjects requiring renal replacement therapy	baseline to 3 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States