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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Vesna D. Garovic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01893658
First received: June 12, 2013
Last updated: February 22, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Acute Interstitial Nephritis
Drug: Omalizumab
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in serum creatinine [ Time Frame: Baseline to three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean individual percentage drop in serum creatinine relative to entry creatinine levels [ Time Frame: baseline to 3 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects returning to their usual baseline creatinine (+25%) or below [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
  • Reduction in Neutrophil gelatinase-associated lipocalcin. [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
    24 hours, 4 hours, and in 3 months after Xolair treatment

  • Percentage of subjects requiring renal replacement therapy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).

Drug: Omalizumab
Other Name: Xolair
Drug: Prednisone
Other Name: Prednisolone
Active Comparator: 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: Prednisone
Other Name: Prednisolone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893658

Contacts
Contact: Joanne D. Ryan 507-266-8668 ryan.joanne@mayo.edu
Contact: Kathleen S Mieras, CCRP 507-284-9187 mieras.kathleen@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Joanne D. Ryan    507-266-8668    ryan.joanne@mayo.edu   
Contact: Kathleen S. Mieras, CCRP    507-284-9187    mieras.kathleen@mayo.edu   
Sub-Investigator: Ladan Zand, M.D.         
Sub-Investigator: Kaiser Lim, M.D.         
Principal Investigator: Vesna D. Garovic, M.D.         
Sponsors and Collaborators
Mayo Clinic
Genentech
Investigators
Principal Investigator: Vesna D. Garovic, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Vesna D. Garovic, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01893658     History of Changes
Other Study ID Numbers: 12-006797
Study First Received: June 12, 2013
Last Updated: February 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Interstitial Nephritis
Nephritis
Tubulointerstitial
Renal disease
Kidney

Additional relevant MeSH terms:
Nephritis
Nephritis, Interstitial
Kidney Diseases
Urologic Diseases
Prednisone
Omalizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014