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

Loma Linda University (LLU)

Status and phase: Terminated; Phase 4

Conditions: Renal Transplant Rejection

Treatments: Drug: Neoral; Drug: Prograf

Study type: Interventional

Funder types: Other

Identifiers

NCT00983645

53271

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Neoral

Active Comparator group

Description:

Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants

Treatment:

Drug: Neoral

Prograf

Active Comparator group

Description:

Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.

Treatment:

Drug: Prograf