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

Phase 4

Terminated

• Conditions: Renal Transplant Rejection
• Interventions: Drug: Prograf; Drug: Neoral

• Registration Number: NCT00983645
• Lead Sponsor: Loma Linda University

Brief 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Primary Completion: 2012-10
• Study Completion: 2013-03
• Results First Submitted: 2015-09-17
• Results First Submitted QC: 2015-09-17
• Results First Posted: 2015-10-20
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prograf	Prograf	Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Neoral	Neoral	Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants

Primary Outcome Measures

Name	Time	Method
Rejection	6 months post-transplant

Secondary Outcome Measures

Name	Time	Method
Renal Function	6 months post-transplant
Lipid Levels	6 months post-transplant
Post-transplant Diabetes Mellitus	6 months post-transplant

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States