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

Primary Purpose

Acute Interstitial Nephritis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

Prednisone

About this trial

This is an interventional treatment trial for Acute Interstitial Nephritis focused on measuring Interstitial Nephritis, Nephritis, Tubulointerstitial, Renal disease, Kidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Omalizumab and Prednisone

Prednisone

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in serum creatinine

Secondary Outcome Measures

Mean individual percentage drop in serum creatinine relative to entry creatinine levels

Percentage of subjects returning to their usual baseline creatinine (+25%) or below

Reduction in Neutrophil gelatinase-associated lipocalcin.

24 hours, 4 hours, and in 3 months after Xolair treatment

Percentage of subjects requiring renal replacement therapy

Full Information

NCT ID

NCT01893658

First Posted

June 12, 2013

Last Updated

December 4, 2018

Sponsor

Mayo Clinic

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01893658

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of patients with a condition of interest that resulted in failure to recruit

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

September 28, 2018 (Actual)

Study Completion Date

September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Interstitial Nephritis

Keywords

Interstitial Nephritis, Nephritis, Tubulointerstitial, Renal disease, Kidney

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omalizumab and Prednisone

Arm Type

Active Comparator

Arm Description

Arm Title

Prednisone

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair

Intervention Description

administration of a single dose together with the standard treatment

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Prednisolone

Intervention Description

standard treatment

Primary Outcome Measure Information:

Title

Change in serum creatinine

Time Frame

Baseline to three months

Secondary Outcome Measure Information:

Title

Mean individual percentage drop in serum creatinine relative to entry creatinine levels

Time Frame

baseline to 3 months

Title

Percentage of subjects returning to their usual baseline creatinine (+25%) or below

Time Frame

baseline to 3 months

Title

Reduction in Neutrophil gelatinase-associated lipocalcin.

Description

24 hours, 4 hours, and in 3 months after Xolair treatment

Time Frame

baseline to 3 months

Title

Percentage of subjects requiring renal replacement therapy

Time Frame

baseline to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult subjects > 18 years old of both genders Biopsy proven acute interstitial nephritis in the native kidneys without evidence of ischemic or glomerular pathology in the biopsy Normal baseline creatinine defined as estimated GFR ≥ 60 ml/min/SA based on MDRD calculation within 1 year prior to renal biopsy 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) No immunosuppressants in the last three months including prednisone 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: Unwillingness to give consent Patients who are Pregnant (positive serum pregnancy test for females) or breast feeding Documented history of an autoimmune disease Inability or unwillingness to take prednisone for the prescribed duration and/or dose Subjects suspected to have non-drug-induced AIN Subjects not meeting the inclusion criteria Subjects with contraindication to administration of omalizumab Prior use of omalizumab Severe hypersensitivity to omalizumab or any component of the product Known elevated IgE level from other disease processes Subjects taking (nonsteroidal antiinflammatory drug) NSAIDs chronically Use of any other investigational agents in the last 30 days 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vesna D. Garovic, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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