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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT01893658
Phase
PHASE2
Status
Withdrawn

Conditions

  • Acute Interstitial Nephritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    administration of a single dose together with the standard treatment
  • Prednisone — DRUG
    standard treatment

Study Details

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.

Key Dates

Start date
Jun 1, 2018
Status verified
Dec 2018
Primary completion
Sep 28, 2018
Completion
Sep 28, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

Change in serum creatinine [ Time Frame: Baseline to three months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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By research site
Mayo Clinic· Rochester, MN

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