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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Transition from tacrolimus based triple therapy with Mycophenolate Mofetil (MMF) and steroids in stable renal transplant patients to low intensity tacrolimus, everolimus and prednisone will be associated with improvement in Glomular Filtration Rate (GFR) and allograft fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low intensity Tacrolimus | Active Comparator | Low tacrolimus, everolimus, and steroids |
|
| Standard of Care | Other | Tacrolimus, mycophenolate mofetil and steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Allograft Fibrosis Assessment | Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen. The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR) | Measure and compare the estimated GFR (using the 4-variable modified MDRD equation) in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen, both at one year and two years post-transplant. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Titte Srinivas, MD | Medical University of South Carolina | Principal Investigator |
| David Taber | Medical University of South Carolina, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31365151 | Derived | Taber DJ, Chokkalingam A, Su Z, Self S, Miller D, Srinivas T. Randomized controlled trial assessing the impact of everolimus and low-exposure tacrolimus on graft outcomes in kidney transplant recipients. Clin Transplant. 2019 Oct;33(10):e13679. doi: 10.1111/ctr.13679. Epub 2019 Sep 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Intensity Tacrolimus | Low tacrolimus, everolimus, and steroids Convert mycophenolate to everolimus (concentration goal of 3-8 ng/mL) with subsequent reduction in exposure to tacrolimus (concentration of 2-5 ng/mL) |
| FG001 | Standard of Care | Tacrolimus, mycophenolate mofetil and steroids Standard of Care: Tacrolimus (concentration goal of 5-12 ng/mL), mycophenolate mofetil and steroids |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Intensity Tacrolimus | Low tacrolimus, everolimus, and steroids Everolimus: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Kidney Allograft Fibrosis Assessment | Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen. The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better. | The number of subjects analyzed for the fibrosis assessment was 15 in each group, because biopsy samples for both baseline and end of follow-up were only able to be obtained from 15 subjects per group. | Posted | Mean | Inter-Quartile Range | % of fibrosis | 1 year |
|
2 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 | Low Intensity Tacrolimus | Low tacrolimus, everolimus, and steroids Everolimus: Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment | Post-randomization hospitalization occurrence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immunosuppression held or modified | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Taber | Medical University of South Carolina | 843-792-3368 | taberd@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2013 | May 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D019984 |
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| Standard of Care | Other | Tacrolimus, mycophenolate mofetil and steroids |
|
| Kidney Allograft Survival | Compare the patient and graft survival rates at one-year post-transplant in each group. | 1 year |
| Percentage of Participants Discontinuing or Modifying Immunosuppressant Use | Measure and compare the rates of immunosuppressant discontinuation and modification for each group. | 2 year |
| Adverse Drug Reactions | Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group. | 2 year |
| Infection | Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group. | 2 year |
Tacrolimus, mycophenolate mofetil and steroids
Standard of Care: Tacrolimus, mycophenolate mofetil and steroids
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Standard of Care | Tacrolimus, mycophenolate mofetil and steroids Standard of Care: Tacrolimus, mycophenolate mofetil and steroids |
|
|
| Secondary | Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR) | Measure and compare the estimated GFR (using the 4-variable modified MDRD equation) in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen, both at one year and two years post-transplant. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | 1 year |
|
|
|
| Secondary | Kidney Allograft Survival | Compare the patient and graft survival rates at one-year post-transplant in each group. | Posted | Number | percentage of patients graft survival | 1 year |
|
|
|
| Secondary | Percentage of Participants Discontinuing or Modifying Immunosuppressant Use | Measure and compare the rates of immunosuppressant discontinuation and modification for each group. | Posted | Number | percentage of participants | 2 year |
|
|
|
| Secondary | Adverse Drug Reactions | Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group. | Posted | Count of Participants | Participants | 2 year |
|
|
|
| Secondary | Infection | Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group. | Posted | Number | percentage of subjects with infection | 2 year |
|
|
|
| 0 |
| 30 |
| 8 |
| 30 |
| 11 |
| 30 |
| EG001 | Standard of Care | Tacrolimus, mycophenolate mofetil and steroids Standard of Care: Tacrolimus, mycophenolate mofetil and steroids | 0 | 30 | 6 | 30 | 6 | 30 |
|
| Infections | Renal and urinary disorders | Non-systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |