Trial · NCT00634049
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
NCT00634049, Phase 3, Completed, Astellas Pharma Inc; results first posted 2016-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi. Trials, record NCT00634049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00634049
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
- NCT number
- NCT00634049
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Aspergillosis, Invasive Fungal Infections
- Interventions
- isavuconazole
- First posted
- 2008-03-12
- Last updated
- 2024-12-11
- Other registries' IDs
- eudract:2006-005003-33
- Results first posted
- 2016-01-11
- Limitations and caveats
Enrollment in the clinical study was suspended in January 2009 pending further characterization of newly identified impurities. After successful study completion resumption of enrollment started in April 2011 for the 9766-CL-0103/WSA-CS-003 study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42, 84 and End of Treatment (EOT [Day 180]) | The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication and Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections\], \[Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections\]; and \[Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success \[Resolution of all attributable clinical symptoms and physical findings\] and \[Resolution of some attributable clinical symptoms and physical findings\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success \[Eradication,Presumed eradication\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success \[≥ 90% improvement,≥ 50% to \< 90% improvement and ≥ 25% to \< 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)\]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | All-cause Mortality Through Day 42 and Day 84 | Baseline to End of Treatment (EOT [Day 180]) | All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days. |
| Secondary | Safety - Overall Number of TEAEs | From the first study drug administration until 28 days after the last dose of study drug | A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | Day 42, 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT | Day 42, 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT | Day 42, Day 84 and End of Treatment (EOT [Day 180]) | Modified Intent-To-Treat population (mITT) | percentage of participants | NUMBER |
| SECONDARY | All-cause Mortality Through Day 42 and Day 84 | Baseline to End of Treatment (EOT [Day 180]) | Intent-To-Treat population (ITT) | percentage of participants | NUMBER |
| SECONDARY | Safety - Overall Number of TEAEs | From the first study drug administration until 28 days after the last dose of study drug | The safety analysis set (SAF) consists of all enrolled participants who received at least one dose of study drug as this was a non-comparative open-label study | participants | NUMBER |
Source ClinicalTrials.gov
Results by group224
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT - Aspergillus [Renally Impaired] | Day 42- Success Rate | 25.0 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT - Aspergillus [Not Renally Impaired] | Day 42- Success Rate | 50.0 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT - Mucorales (Primary Therapy) | Day 42- Success Rate | 14.3 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT - Mucorales (Refractory) | Day 42- Success Rate | 9.1 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT - Mucorales (Intolerant) | Day 42- Success Rate | 0 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT- Other Filamentous Fungi | Day 42- Success Rate | 47.1 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT- Other Mould Species Only | Day 42- Success Rate | 28.6 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT- Other Dimorphic Fungi | Day 42- Success Rate | 41.4 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT- Other Non-Candida Yeast | Day 42- Success Rate | 36.4 | percentage of participants | |
| Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). | mITT-Other Mixed Infection | Day 42- Success Rate | 13.3 | percentage of participants |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isavuconazole | 149 | |
| Overall Study | COMPLETED | Isavuconazole | 146 | |
| Overall Study | NOT COMPLETED | Isavuconazole | 3 |
Source ClinicalTrials.gov
Adverse events382
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | Renally Impaired (RI) | 4 | 59 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Not Renally Impaired (NRI) | 2 | 87 | |
| other | Neutropenia | Blood and lymphatic system disorders | Renally Impaired (RI) | 6 | 59 | |
| other | Neutropenia | Blood and lymphatic system disorders | Not Renally Impaired (NRI) | 2 | 87 | |
| other | Atrial fibrillation | Cardiac disorders | Renally Impaired (RI) | 4 | 59 | |
| other | Atrial fibrillation | Cardiac disorders | Not Renally Impaired (NRI) | 1 | 87 | |
| other | Sinus tachycardia | Cardiac disorders | Renally Impaired (RI) | 3 | 59 | |
| other | Sinus tachycardia | Cardiac disorders | Not Renally Impaired (NRI) | 2 | 87 | |
| other | Tachycardia | Cardiac disorders | Renally Impaired (RI) | 4 | 59 | |
| other | Tachycardia | Cardiac disorders | Not Renally Impaired (NRI) | 4 | 87 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Renally Impaired (RI) | ||
| Total, all-cause mortality | Not Renally Impaired (NRI) | ||
| Total, other adverse events | Renally Impaired (RI) | 54 | 59 |
| Total, other adverse events | Not Renally Impaired (NRI) | 68 | 87 |
| Total, serious adverse events | Renally Impaired (RI) | 43 | 59 |
| Total, serious adverse events | Not Renally Impaired (NRI) | 46 | 87 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Renally Impaired (RI) vs Not Renally Impaired (NRI): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00634049
GET https://conductscience.org/api/trials/v1/NCT00634049/results?page=2