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

NCT ID: NCT01893658

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-09-28

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.

Conditions

Acute Interstitial Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Omalizumab and 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).

Group Type: ACTIVE_COMPARATOR

Omalizumab

Intervention Type: DRUG

administration of a single dose together with the standard treatment

Prednisone

Intervention Type: DRUG

standard treatment

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).

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

standard treatment

Interventions

Omalizumab

administration of a single dose together with the standard treatment

Intervention Type: DRUG

Prednisone

standard treatment

Intervention Type: DRUG

Other Intervention Names

Xolair; Prednisolone

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.

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Vesna D. Garovic, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vesna D. Garovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-006797

Identifier Type: -

Identifier Source: org_study_id