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

April 28, 2016 updated by: Loma Linda University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rejection
Time Frame: 6 months post-transplant
6 months post-transplant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Pedro Baron, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (ESTIMATE)

September 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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