Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation

March 20, 2006 updated by: Vanderbilt University

Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplant Recipients.

A prospective, single center, open-label, randomized trial of Thymoglobulin induction and sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased donor kidney transplant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may improve graft function as measured by serum creatinine and calculated GFR and improve long-term outcomes following kidney transplantation. We conducted a prospective, randomized, single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary cadaver of non-HLA identical living donor recipients are randomized to received either sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12 ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID, and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound complications.

Study Type

Interventional

Enrollment

80

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center/Nashville VA

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Primary cadaver or non-HLA identical living donor kidney transplant. -

Exclusion Criteria:

HIV HCV Pregnancy Age < 18 years Malignancy

-

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient and graft survival
Serum creatinine
Biopsy proven acute rejection

Secondary Outcome Measures

Outcome Measure
wound infections
Hyperlipidemia
post-transplant diabetes
lymphoceles

Collaborators and Investigators

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

Sponsor

Vanderbilt University

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: A. Tarik Kizilisik, M.D., Vanderbilt University Medical Center

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

April 1, 2004

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 21, 2006

Last Update Submitted That Met QC Criteria

March 20, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 031041

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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