NCT00305396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
Last Updated

March 21, 2006

Status Verified

March 1, 2006

First QC Date

March 20, 2006

Last Update Submit

March 20, 2006

Conditions

Kidney Transplantation

Keywords

Kidney transplantationimmunosuppressionsirolimusThymoglobulin

Outcome Measures

Primary Outcomes (3)

  • Patient and graft survival

  • Biopsy proven acute rejection

  • Serum creatinine

Secondary Outcomes (4)

  • Hyperlipidemia

  • post-transplant diabetes

  • wound infections

  • lymphoceles

Interventions

SirolimusDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • HIV HCV Pregnancy Age \< 18 years Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center/Nashville VA

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.

    PMID: 12438948BACKGROUND

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • A. Tarik Kizilisik, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

April 1, 2004

Study Completion

March 1, 2005

Last Updated

March 21, 2006

Record last verified: 2006-03

Locations

US(1)