A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Study Overview
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Brief Summary
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This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.

Detailed Description
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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.

Official Title
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A Prospective, Open-label, Randomized Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity

Conditions
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Renal Transplant Rejection

Intervention / Treatment
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* Drug: Prograf
* Drug: Neoral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cadaveric or Living Donors 18 years old or greater Primary renal transplants Hispanic ethnicity Exclusion Criteria: Prior renal transplant Multi-organ transplant Recipient with history of Diabetes Mellitus PRA > 20% Cold Ischemia Time > 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neoral<br>Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants | Drug: Neoral<br>* Cyclosporine (Neoral) starting dose 3mg/kg PO BID<br>* Other names: Cyclosporine;|
| Active Comparator: Prograf<br>Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids. | Drug: Prograf<br>* Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID<br>* Other names: Tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rejection |  | 6 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function |  | 6 months post-transplant | 
| Post-transplant Diabetes Mellitus |  | 6 months post-transplant | 
| Lipid Levels |  | 6 months post-transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Immunosuppression