| Trial ID: | L0737 |
| Source ID: | NCT00446459
|
| Associated Drug: |
Mycophenolate Mofetil (Cellcept)
|
| Title: |
Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00446459/results
|
| Conditions: |
Kidney Failure, Chronic|Diabetic Nephropathies|Glomerulonephritis, IGA|Hypertension, Renal
|
| Interventions: |
DRUG: mycophenolate mofetil (CellCept)
|
| Outcome Measures: |
Primary: The Number of Subjects With a 10% Decrease in PRA Level at Month 8., Enrollment to month 8 | Secondary: The Number of Subjects With Significant Infections up to Month 12., The number of infections while on-study up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study., From enrollment to month 12.|The Number of Kidney Transplant up to 12 Months., The number of kidney transplants up to month 12. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for infection over 12 months or until they seperated from the study., Enrollment to month 8 or month 12 post enrollment.|The Number of Pariticpants With a White Blood Cell Count Below 2.0 Thousand (Low) or Total IgG/IgM Titers Below Range (620-1490 mg/dL)., The number of subjects with adverse hematologic effects with MMF while on-study. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for hematologic effects up to 12 months., Enrollment to month 12.|The Number of Transplants With a Negative Crossmatch at Transplant., The number negative crossmatch transplants up to month 12. Positivie crossmatch transplant carries a higher risk for rejection. Subjects who's PRA decreased by 10% at month 8 and who went on to the Mycophenolate mofetil + Rituximab study were followed to month 8. Those subjects who stayed on the Mycophenolate mon-therapy study were observed for negative crossmatch transplants to 12 months., Number of Transplants with a Negative Crossmatch.
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| Sponsor/Collaborators: |
Sponsor: University of Washington | Collaborators: Hoffmann-La Roche
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
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| Completion Date: |
2008-12
|
| Results First Posted: |
2010-03-30
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| Last Update Posted: |
2010-04-15
|
| Locations: |
Universtiy of Washington Medical Center, Seattle, Washington, 98195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00446459
|
