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The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Standard of Care CNI immunosuppression | |
| 2 | Experimental | Calcineurin inhibitor withdrawal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcineurin inhibitor withdrawal | Drug | stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsy Proven Rejection | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine at 36 Months (End of Study) | 36 months +/- 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| WBC | White Blood Cell count | 36 months +/- 60 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Knechtle, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CNI Control Post Campath 1H | Standard of Care CNI immunosuppression |
| FG001 | CNI Withdrawal Post Campath 1H | Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CNI Control Post Campath 1H | Standard of Care CNI immunosuppression |
| BG001 | CNI Withdrawal Post Campath 1H | Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Biopsy Proven Rejection | Posted | Number | participants | 3 years |
|
|
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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 | CNI Control Post Campath 1H | Standard of Care CNI immunosuppression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillaiton | Cardiac disorders | MedDRA11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | UW Madison | 608-263-2565 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Serum Creatinine at 36 Months (End of Study) | Posted | Mean | Standard Deviation | mg/dl | 36 months +/- 60 days |
|
|
|
| Other Pre-specified | WBC | White Blood Cell count | Posted | Mean | Standard Deviation | K/ul | 36 months +/- 60 days |
|
|
|
| 11 |
| 20 |
| 10 |
| 20 |
| EG001 | CNI Withdrawal Post Campath 1H | Calcineurin inhibitor withdrawal Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy | 8 | 20 | 11 | 20 |
| encephalitis | Nervous system disorders | Systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | Systematic Assessment |
|
| kidney transplant rejection | Immune system disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | unknown etiology reuired hospitalization |
|
| hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| cytomegalovirus | Infections and infestations | Systematic Assessment | required hospitalization |
|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment | required hospitalization |
|
| thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| thryoidectomy | Surgical and medical procedures | Systematic Assessment | secondary to thyroid cancer |
|
| campylobacteremia | Infections and infestations | Systematic Assessment |
|
| hernia repair | Surgical and medical procedures | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura (ITP), | Blood and lymphatic system disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Camplobacter gastroenteritis | Infections and infestations | Systematic Assessment |
|
| gastritis (viral) | Gastrointestinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Coronary artery bypass grafting (CABG) | Surgical and medical procedures | Systematic Assessment |
|
| Varicella Zoster | Infections and infestations | Systematic Assessment |
|
| Cryptococcal Meningitis | Infections and infestations | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | Systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Dental Abcess | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| BK Polyoma viuria | Infections and infestations | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| sinusitis | Infections and infestations | Systematic Assessment |
|
| Cytomegalovirus | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| E. Coli Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Klebsiella pneumoniae Urinary Tract infection | Infections and infestations | Systematic Assessment |
|
| Acinetobacter Baumannii Urinary Tract infection | Infections and infestations | Systematic Assessment |
|
| Streptococcal Urinary Tract infection | Infections and infestations | Systematic Assessment |
|
| Iritis, left eye | Eye disorders | Systematic Assessment |
|
| CMV retinitis | Infections and infestations | Systematic Assessment |
|
| Epstein Barr Virus | Infections and infestations | Systematic Assessment |
|
| Boil (groin) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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