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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
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The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:
Patients with high level of preformed antibodies (panel reactive antibodies [PRA]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMVIG followed by PP | No Intervention | MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMVIG | Drug | 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor | The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation. | four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor Graft Survival | 5 years | |
| Monitor Patient Survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Leone, MD, PhD | Lifelink Healthcare Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LifeLink HealthCare Institute | Tampa | Florida | 33606 | United States |
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| Label | URL |
|---|---|
| Tampa General Medical Group | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CMVIG Followed by PP | MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Highly Sensitized Patients | Highly-sensitized patients were defined as those having PRA >/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | >/= 18 years old |
| 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 | The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor | The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation. | Posted | Number | percent of subjects becoming compatible | four weeks |
|
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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 | Highly Sensitized Patients | Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Leone | Tampa General Hospital | 813-844-5666 | jpleone@tgh.org |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C045781 | cytomegalovirus-specific hyperimmune globulin |
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| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Percent of subjects with PRA >/= 20% in last 12 months | Number | percent of subjects with elevated PRA |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Monitor Graft Survival | Not Posted | 5 years |
| Secondary | Monitor Patient Survival | Not Posted | 5 years |
| 0 |
| 20 |
| 0 |
| 20 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |