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| ID | Type | Description | Link |
|---|---|---|---|
| H-2003-0493 | Other Identifier | UW IRB | |
| A536758 | Other Identifier | UW Madison | |
| SMPH/PEDIATRICS/PEDIATRICS | Other Identifier | UW Madison |
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Enrollment suspended pending protocol revision to change study to observational
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The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Campath 1-H | Experimental | Campath 1-H |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Campath-1H | Drug | two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Graft Rejection | at 1, 3, 6, 12, and 24 months | |
| Participant Graft Survival | at 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Glomerular Filtration Rate (EGFR) | Measure of renal function | at 1, 6, 12 and 24 months |
| Number of Participants With Infection | Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon M Bartosh, MD | University of Wisconsin, Madison | Study Chair |
| Sharon M Bartosh, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Campath 1-H | Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Campath 1-H | Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Graft Rejection | Posted | Count of Participants | Participants | at 1, 3, 6, 12, and 24 months |
|
|
up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Campath 1-H | Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyuria | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Bartosh | University of Wisconsin - Madison | (608) 265-6020 | smbartosh@wisc.edu |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| up to 24 months |
| Number of Participants With Malignancy | up to 24 months |
| Growth Post-transplant Reported by Height Z Score | A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean. | up to 24 months |
| Number of Participants With Hypertension | up to 24 months |
| Number of Participants With Hyperlipidemia | up to 24 months |
| Participant Survival | at 6, 12, and 24 months |
| Number of Participant With Diabetes Mellitus | up to 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Participant Graft Survival | Posted | Count of Participants | Participants | at 6, 12, and 24 months |
|
|
|
| Secondary | Estimated Glomerular Filtration Rate (EGFR) | Measure of renal function | One participant was on dialysis at 2 years, not included in the analysis | Posted | Mean | Full Range | ml/min/1.73m^2 | at 1, 6, 12 and 24 months |
|
|
|
| Secondary | Number of Participants With Infection | Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK) | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Number of Participants With Malignancy | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Growth Post-transplant Reported by Height Z Score | A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean. | One participant was on dialysis at 2 years, not included in the analysis | Posted | Mean | Full Range | z-score | up to 24 months |
|
|
|
| Secondary | Number of Participants With Hypertension | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Number of Participants With Hyperlipidemia | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| Secondary | Participant Survival | Posted | Count of Participants | Participants | at 6, 12, and 24 months |
|
|
|
| Secondary | Number of Participant With Diabetes Mellitus | Posted | Count of Participants | Participants | up to 24 months |
|
|
|
| 0 |
| 33 |
| 2 |
| 33 |
| 29 |
| 33 |
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Increase Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Gingivitis | Infections and infestations | Systematic Assessment |
|
| influenza | Infections and infestations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Pseudomonas bacteremia | Infections and infestations | Systematic Assessment |
|
| Varicella | Infections and infestations | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Ureteral Stricture | Renal and urinary disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
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| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| Epigastric Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Hydroureter | Renal and urinary disorders | Systematic Assessment |
|
| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Increased Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Pyuria | Renal and urinary disorders | Systematic Assessment |
|
| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| Urinary Eosinophils | Renal and urinary disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsillar cervical, axillary, inguinal hypertrophy | Immune system disorders | Systematic Assessment |
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| Anemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperphosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Mouth Ulcers | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hives | Immune system disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Joint Pain | General disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphoid hyperplasia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fine tremor at rest | Nervous system disorders | Systematic Assessment |
|
| Fracture L5 | Injury, poisoning and procedural complications | Systematic Assessment |
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| High Blood Pressure | Vascular disorders | Systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | Systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | Systematic Assessment |
|
| Ottis Media | Ear and labyrinth disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| 12 months |
|
|
| 24 months |
|
|
| CMV Viremia |
|
| CMV disease |
|
| EBV Viremia |
|
| EBV disease |
|
|
| 24 months |
|
|