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Lack of patients with a condition of interest that resulted in failure to recruit
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose). |
|
| Prednisone | Active Comparator | Standard clinical therapy with prednisone.
If patients weigh less than 60 Kg, the dose will be adjusted accordingly (to equal 1mg/kg/day of prednisone as the starting dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | administration of a single dose together with the standard treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum creatinine | Baseline to three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vesna D. Garovic, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| C564356 | Acute Tubulointerstitial Nephritis |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Open Label
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| Prednisone | Drug | standard treatment |
|
|
| Reduction in Neutrophil gelatinase-associated lipocalcin. | 24 hours, 4 hours, and in 3 months after Xolair treatment | baseline to 3 months |
| Percentage of subjects requiring renal replacement therapy | baseline to 3 months |
| D052801 | Male Urogenital Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |