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This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.
This study aims to include Hispanics who have undergone a renal transplant to determine the specific outcome after renal transplantation, assuming that ethnic groups require different immunosuppressant regimens. Trough levels in transplant recipients determine the dosing requirements for Tacrolimus and Cyclosproine. It has been recently found, however, that testing cyclosporine levels in the blood 2 hours after taking cyclosporine is more effective in dosing cyclosprine for renal transplant patients than trough levels. The specific study aims include comparing the cyclosporine monitoring in patients with trough and C2 levels, and adjusting immunosuppression based on C2 levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoral | Active Comparator | Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants |
|
| Prograf | Active Comparator | Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rejection | 6 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function | 6 months post-transplant | |
| Post-transplant Diabetes Mellitus | 6 months post-transplant | |
| Lipid Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Baron, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9500626 | Background | Neylan JF. Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group. Transplantation. 1998 Feb 27;65(4):515-23. doi: 10.1097/00007890-199802270-00011. | |
| 11884934 | Background | First MR, Gerber DA, Hariharan S, Kaufman DB, Shapiro R. Posttransplant diabetes mellitus in kidney allograft recipients: incidence, risk factors, and management. Transplantation. 2002 Feb 15;73(3):379-86. doi: 10.1097/00007890-200202150-00011. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoral | Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID |
| FG001 | Prograf | Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids. Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoral | Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID |
| BG001 | Prograf | Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids. Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID |
| 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 | Rejection | Data cannot be located for analysis. | Posted | 6 months post-transplant |
|
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Standard practice
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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 | Neoral | Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID |
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A limitation to this study is early termination leading to a small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pedro Baron | Loma Linda University Medical Center Transplantation Institute | 909-558-3636 | 36792 | pbaron@llu.edu |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
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| Neoral | Drug | Cyclosporine (Neoral) starting dose 3mg/kg PO BID |
|
|
| 6 months post-transplant |
| 11152233 | Background | Jindal RM, Hjelmesaeth J. Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. No abstract available. |
| 10213717 | Background | Knoll GA, Bell RC. Tacrolimus versus cyclosporin for immunosuppression in renal transplantation: meta-analysis of randomised trials. BMJ. 1999 Apr 24;318(7191):1104-7. doi: 10.1136/bmj.318.7191.1104. |
| 9112351 | Background | Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Renal Function | Data cannot be located for analysis. | Posted | 6 months post-transplant |
|
|
| Secondary | Post-transplant Diabetes Mellitus | Data cannot be located for analysis. | Posted | 6 months post-transplant |
|
|
| Secondary | Lipid Levels | Data cannot be located for analysis. | Posted | 6 months post-transplant |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Prograf | Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids. Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID | 0 | 7 | 0 | 7 |
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| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |