Acute Interstitial NephritisPhase 2NCT01893658
Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
A Phase 2 study testing Omalizumab and Prednisone in people with Acute Interstitial Nephritis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Interstitial Nephritis
- What is being tested?
- Omalizumab and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 28 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 not meeting the inclusion criteria
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Omalizumab, Prednisone
- Keywords
- Interstitial Nephritis, Nephritis, Tubulointerstitial, Renal disease, Kidney
- Medical subject headings
- Acute Tubulointerstitial Nephritis, Nephritis, Interstitial, Nephritis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
administration of a single dose together with the standard treatment
PrednisoneDrug
Also called Prednisolone
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine
Measured: Baseline to three months
Secondary outcomes (4)
Mean individual percentage drop in serum creatinine relative to entry creatinine levels
Measured: baseline to 3 months
Percentage of subjects returning to their usual baseline creatinine (+25%) or below
Measured: baseline to 3 months
Reduction in Neutrophil gelatinase-associated lipocalcin.
24 hours, 4 hours, and in 3 months after Xolair treatment
Measured: baseline to 3 months
Percentage of subjects requiring renal replacement therapy
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start1 Jun 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Why it stopped: Lack of patients with a condition of interest that resulted in failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Interstitial NephritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Vesna D. Garovic, M.D., Mayo Clinic
- Investigators
- Vesna D. Garovic, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893658
- Sponsor's protocol ID
- 12-006797
- Status last verified
- Dec 2018
- First submitted
- 12 Jun 2013
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
- ClinicalTrials.gov ID
- NCT01893658
- Acronym / sponsor ID
- 12-006797
- Conditions
- Acute Interstitial Nephritis
- Keywords
- Interstitial Nephritis, Nephritis, Tubulointerstitial, Renal disease, Kidney
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patients with a condition of interest that resulted in failure to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab and Prednisone | Active comparator | Drug: Omalizumab, Drug: PrednisoneOmalizumab 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). |
| Prednisone | Active comparator | Drug: PrednisoneStandard 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmalizumabAlso: Xolairadministration of a single dose together with the standard treatment | Drug | Omalizumab and Prednisone |
| PrednisoneAlso: Prednisolonestandard treatment | Drug | Omalizumab and Prednisone, Prednisone |
Primary outcome
Change in serum creatinine
Time frame: Baseline to three months
4 secondary outcomes
Mean individual percentage drop in serum creatinine relative to entry creatinine levels
Time frame: baseline to 3 months
Percentage of subjects returning to their usual baseline creatinine (+25%) or below
Time frame: baseline to 3 months
Reduction in Neutrophil gelatinase-associated lipocalcin.
Time frame: baseline to 3 months
Percentage of subjects requiring renal replacement therapy
Time frame: baseline to 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesna D. Garovic, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab and Prednisone in people with Acute Interstitial Nephritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine (time frame: Baseline to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.