NCT00983645

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Renal Transplant Rejection

Interventions

Type	Name	Description
DRUG	Prograf	Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
DRUG	Neoral	Cyclosporine (Neoral) starting dose 3mg/kg PO BID

Timeline

• Start date: 2004-10-01
• Primary completion: 2012-10-01
• Completion: 2013-03-01
• First posted: 2009-09-24
• Last updated: 2016-06-03
• Results posted: 2015-10-20

Locations

1 site across 1 country: United States