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The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 intravenous immune globulin | Other | Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list |
|
| Group 2 intravenous immune globulin | Other | Intravenous immune globulin for patients who have living donors with positive crossmatch results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous immune globulin | Drug | 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of Donor Specific Antibodies | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Negative B and T Cell Crossmatch | 1year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Okechukwu Ojogho, MD | Loma Linda Universtiy Adventist Health Sciences Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Intravenous Immune Globulin no Living Donor | Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments |
| FG001 | Group 2 Intravenous Immune Globulin With Living Donor | Patients who have living donors with positive crossmatch results. intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVIG no Living Donor | Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list |
| BG001 | IVIG With Living Donor |
| 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 | Elimination of Donor Specific Antibodies | Study was terminated and no data for the outcome was collected/analyzed because it could not be located. | Posted | 1 year |
|
|
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Serious and non-serious adverse events were not collected/assessed.
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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 | Group 1 Intravenous Immune Globulin | Group 1 with Intravenous immune globulin with no living donor |
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A limitation to this study is early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pedro Baron | Loma Linda University Medical Center | 909-558-6792 | PBaron@llu.edu |
| 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 |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Intravenous immune globulin for patients who have living donors with positive crossmatch results. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Secondary | Negative B and T Cell Crossmatch | Study was terminated and no data for the outcome was collected/analyzed because it could not be located. | Posted | 1year |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group 2 Intravenous Immune Globulin | Group 2 intravenous immune globulin WITH living donor | 0 | 0 | 0 | 0 |
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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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |