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A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin |
|
| 2 | No Intervention | Patient will remain on calcineruin inhibitor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin | Drug | Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Survival | 3 years |
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Inclusion Criteria:
Patient is the recipient of a cadaveric or living donor renal transplant.
Patient was > 12 years of age at the time of transplant.
Patient is at least 3 months post-transplant.
Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
Patient has one of the following risk factors for chronic renal allograft failure:
I. Serum creatinine > 2.0 mg/dL 3 months or later post-transplant in males patients.
II. Serum creatinine > 1.7 mg/dL 3 months or later post-transplant in female patients.
III. Serum > 30% increased over post discharge nadir.
Patients had a renal biopsy that shows chronic allograft nephropathy.
Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants.
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Langone, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapamycin | pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| CYA/Prograf |
Patient will remain on calcineurin inhibitor,CYA/Prograf |
| COMPLETED |
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| NOT COMPLETED |
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approximately 30 patients will be randomized in a 2:1 ratio: two patients will be converted to Rapamycin-based immunosuppression for each patient randomized to continue calcineurin inhibitor based immunosuppression.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapamycin | pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 |
| BG001 | CYA/Prograf | Patient will remain on calcineurin inhibitor,CYA/Prograf |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Graft Survival | Posted | Median | 95% Confidence Interval | participants | 3 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 | Rapamycin Group | 9 | 13 | 0 | 13 | |||
| EG001 | CNI Group | 2 | 7 | 0 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| acute kidney failure | Renal and urinary disorders | Systematic Assessment |
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| dehydration | Vascular disorders | Systematic Assessment |
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| hip replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| acute rejection | Renal and urinary disorders | Systematic Assessment |
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| total abdominal hysterectomy and salpingectomy | Reproductive system and breast disorders | Systematic Assessment |
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| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Langone | Vanderbilt Medical Center | 615-936-1179 | anthony.langone@vanderbilt.edu |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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