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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rATG 4 doses | Active Comparator | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
|
| rATG 3 doses | Active Comparator | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite End Point of Acute Rejection, Graft Loss or Patient Death | Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy. | Ongoing | |
| Incidence of Infections | Not defined | |
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Inclusion Criteria:
Exclusion Criteria:
Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
History of a positive cross-match with the donor.
Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.
Patients who have previously received a kidney transplant.
Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
History of noncompliance.
History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
Multiple organ transplant recipient.
Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
Known contraindication to administration of rabbit antithymocyte globulin.
Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3
Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.
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| Name | Affiliation | Role |
|---|---|---|
| E. Steve Woodle, MD | University of Cincinnati | Principal Investigator |
| Adele Rike, PharmD | The Christ Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preloading Induction With Thymoglobulin | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
| FG001 | Preloading Induction With Thymoglobulin® X 3 Doses | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preloading Induction With Thymoglobulin | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
| 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 | Composite End Point of Acute Rejection, Graft Loss or Patient Death | Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death | Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose). | Posted | Number | participants | 6 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 | Preloading Induction With Thymoglobulin | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Banff 1A Rejection | Renal and urinary disorders | Non-systematic Assessment | Patient was admitted for acute renal failure. Biopsy showed Banff 1A rejection. Patient treated with solumedrol and IVIG. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever / Chills | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rita Alloway | University of Cincinnati | 513-558-1568 | Rita.Alloway@uc.edu |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Thymoglobulin | Drug | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
|
|
| Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection |
| Not defined |
| Severity of Biopsy-proven Rejection Using Banff 97 Criteria | Not defined |
| Serum Creatinine | Post-operative days 1-7, 30, 90 and 6 months |
| Malignancy | Undefined |
| BG001 | Preloading Induction With Thymoglobulin® X 3 Doses | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Preloading Induction With Thymoglobulin® X 3 Doses | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
|
|
| Secondary | Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy. | Not Posted | Ongoing |
| Secondary | Incidence of Infections | Not Posted | Not defined |
| Secondary | Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection | Not Posted | Not defined |
| Secondary | Severity of Biopsy-proven Rejection Using Banff 97 Criteria | Not Posted | Not defined |
| Secondary | Serum Creatinine | Not Posted | Post-operative days 1-7, 30, 90 and 6 months |
| Secondary | Malignancy | Not Posted | Undefined |
| 2 |
| 6 |
| 4 |
| 6 |
| EG001 | Preloading Induction With Thymoglobulin® X 3 Doses | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF anti-thymocyte globulin (rabbit) : Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF | 3 | 5 | 3 | 5 |
|
| Renal Allograft Dysfunction | Renal and urinary disorders | Non-systematic Assessment | Patient was admitted for renal allograft dysfunction. Biopsy was negative for rejection. |
|
| Acute Renal Failure / Anemia | Renal and urinary disorders | Non-systematic Assessment | Patient was admitted for acute renal failure and anemia. Biopsy was negative for rejection. Anemia was treated with Aranesp |
|
| Fever/Acute Renal Failure/Acidosis | Renal and urinary disorders | Non-systematic Assessment | Patient was admitted for fever of unclear etiology, acute renal failure and acidosis. Biopsy was negative for rejection. Patient treated with IV fluids for acidso |
|
| Increased Serum Creatinine | Renal and urinary disorders | Non-systematic Assessment | Patient was admitted for a kidney biopsy due to a bump in her scr. Preliminary biopsy report shows diffuse inflammation, diffuse C4d positivity, humoral and cellular rejection with possible superimposed pyelonephritis. |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Fever > 102°F | Immune system disorders | Non-systematic Assessment |
|
| Body Aches | General disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| PLT < 100,000 cells/mm3 | Investigations | Non-systematic Assessment |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |