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| ID | Type | Description | Link |
|---|---|---|---|
| CRAD001AUS191T | Other Identifier | Other |
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Feasibility
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.
The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus conversion | Experimental | Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to take everolimus 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects will be weaned off of all other immunosuppression medicines when dialysis starts. |
|
| Control | No Intervention | Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to continue on current immunosuppressive regimen. Subjects will be weaned off of all immunosuppression medicines when dialysis starts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA) | Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Return to Dialysis Dependence | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashtar Chami, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus Conversion | Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started. |
| FG001 | Control | Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus Conversion | Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started. |
| BG001 |
| 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 | Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA) | Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive | Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur. | Posted | 36 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 | Everolimus Conversion | Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashtar Chami | Emory University | 404-712-7735 | ashtar.chami@emory.edu |
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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 |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Control |
Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Control |
Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started. |
|
| Secondary | Incidence of Return to Dialysis Dependence | Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur. | Posted | 36 months |
|
|
| 1 |
| 1 |
| 0 |
| 1 |
| EG001 | Control | Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started. | 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 |