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

NCT01893658 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 12-006797
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Interstitial Nephritis; Nephritis; Tubulointerstitial; Renal disease; Kidney

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine

  Baseline to three months

Secondary Outcomes (4)

• 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

• Percentage of subjects requiring renal replacement therapy

  baseline to 3 months

Study Arms (2)

Omalizumab and Prednisone

ACTIVE COMPARATOR

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).

Drug: Omalizumab; Drug: Prednisone

Prednisone

ACTIVE COMPARATOR

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).

Drug: Prednisone

Interventions

Omalizumab DRUG

administration of a single dose together with the standard treatment

Also known as: Xolair

Omalizumab and Prednisone

Prednisone DRUG

standard treatment

Also known as: Prednisolone

Omalizumab and Prednisone; Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Acute Tubulointerstitial Nephritis; Nephritis, Interstitial; Nephritis; Kidney Diseases

Interventions

Omalizumab; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols

Study Officials

• Vesna D. Garovic, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2018
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

US (1)