Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
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| ClinicalTrials.gov Identifier: NCT00087022 |
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Recruitment Status :
Completed
First Posted : July 12, 2004
Results First Posted : September 12, 2018
Last Update Posted : November 27, 2018
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Sponsor:
Heidelberg Pharma AG
Information provided by (Responsible Party):
Heidelberg Pharma AG
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Condition |
Kidney Cancer |
| Interventions |
Biological: girentuximab Other: placebo |
| Enrollment | 864 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Intervention | Placebo |
|---|---|---|
 Arm/Group Description |
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex, girentuximab, and WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24). girentuximab: Given IV |
Patients receive placebo IV over 15 minutes once weekly for 24 weeks. placebo: Given IV |
| Period Title: Overall Study | ||
| Started [1] | 433 | 431 |
| Treated (Safety Population) | 431 | 424 |
| Completed | 379 | 376 |
| Not Completed | 54 | 55 |
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[1]
ITT Population
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Baseline Characteristics
| Arm/Group Title | Intervention | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24). girentuximab: Given IV |
Patients receive placebo IV over 15 minutes once weekly for 24 weeks. placebo: Given IV |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 433 | 431 | 864 | |
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Baseline Analysis Population Description |
All patients that were enrolled were included in the ITT population used for efficacy analysis; only 855 patients received at least one dose of study treatment and were analyzed for safety (Safety Population, SP)
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 433 participants | 431 participants | 864 participants | |
| 58.2 (9.83) | 57.8 (10.1) | 58.0 (9.98) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 433 participants | 431 participants | 864 participants | |
| Female |
157 36.3%
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133 30.9%
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290 33.6%
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| Male |
276 63.7%
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298 69.1%
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574 66.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Head of R&D |
| Organization: | Heidelberg Pharma AG (previously Wilex AG) |
| EMail: | info@hdpharma.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heidelberg Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00087022 |
| Obsolete Identifiers: | NCT00209183 |
| Other Study ID Numbers: |
WX-2003-07-HR WILEX-WX-2003-07-HR ( Other Identifier: WILEX ) ARISER ( Other Identifier: WILEX ) UCLA-0404015-01 ( Other Identifier: UCLA ) CDR0000372830 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-2012-00491 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) |
| First Submitted: | July 8, 2004 |
| First Posted: | July 12, 2004 |
| Results First Submitted: | July 2, 2018 |
| Results First Posted: | September 12, 2018 |
| Last Update Posted: | November 27, 2018 |