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Withdrawn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

First listed
Jul 9, 2013
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-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MN

Related Studies