Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina, CP1900
      • Ciudad de Bs As, Argentina
      • Cordoba, Argentina
      • Cordoba, Argentina, 5000
    • Capital Ferderal
      • Buenos Aires, Capital Ferderal, Argentina, 1093
      • Buenos Aires, Capital Ferderal, Argentina, 1155
      • Buenos Aires, Capital Ferderal, Argentina, 1425
      • Buenos Aires, Capital Ferderal, Argentina, C1118AT
      • Buenos Aires, Capital Ferderal, Argentina, C1425APQ
  • Australia
      • Camperdown, Australia, NSW 2050
      • Parkville, Australia, 3050
      • Randwick, Australia, 2031
      • Westmead, Australia, 2145
      • Woodville South, Australia, SA 5011
      • Woolloongabba, Australia, QLD 4102
  • Austria
      • Wien, Austria, A-1090
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
    • Quebec
      • Cote du Palais, Quebec, Canada, G1R 2J6
      • Montreal, Quebec, Canada, H2L 4M1
  • Chile
      • Puente Alto, Chile
      • Santiago, Chile
      • Talca, Chile
      • Vina del Mar, Chile
  • Cyprus
      • Nicosia, Cyprus, 1102
  • France
      • Montpellier Cedex, France, 34059
      • Paris Cedex 15, France, 75747
  • Germany
      • Munster, Germany, 48149
  • Greece
      • Athens, Greece, 11527
      • Thessaloniki, Greece, 54642
  • Hungary
      • Budapest, Hungary, 1083
      • Debrecen, Hungary, 4012
      • Pecs, Hungary, 7621
      • Szeged, Hungary, 6720
  • Italy
      • Bari, Italy, 70124
      • Cagliari, Italy, 09134
      • Torino, Italy, 10126
  • Norway
      • Oslo, Norway, 0027
  • Portugal
      • Carnaxide-lisboa, Portugal, 2795-563
      • Coimbra, Portugal, 3049
      • Lisboa, Portugal, 81050
  • Singapore
      • Singapore, Singapore, 169608
  • South Africa
      • Cape Town, South Africa, 7925
      • Cape Town, South Africa, 8001
      • Johannesburg, South Africa, 2193
  • Spain
      • Barcelona, Spain, 08036
      • La Coruã'a, Spain, 15006
      • La Laguna / Santa Cruz de Tenerife, Spain, 38320
      • Madrid, Spain, 28040
      • Madrid, Spain, 28041
      • Santander, Spain, 39008
      • Valencia, Spain, 46009
  • Sweden
      • Uppsala, Sweden, SE-751 85
  • Taiwan
      • Taipei, Taiwan, 100
  • Turkey
      • Antalya, Turkey, 07070
      • Istanbul, Turkey, 34390
      • Izmir, Turkey, 35100
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
      • Leicester, United Kingdom, LE5 4PW
      • Manchester, United Kingdom, M13 9WL
  • United States
    • California
      • San Diego, California, United States, 92123
      • San Francisco, California, United States, 94143
    • Colorado
      • Denver, Colorado, United States, 80262
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Gainesville, Florida, United States, 32610
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Chicago, Illinois, United States, 60612-3824
    • Maine
      • Portland, Maine, United States, 04102
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Detroit, Michigan, United States, 48202
    • New York
      • New York, New York, United States, 10029
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106
      • Toledo, Ohio, United States, 43614
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19129
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77225

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dialysis patients who will be receiving their first kidney transplant
  • Weight over 88 pounds (lbs.)

Exclusion Criteria:

  • Very high cholesterol levels
  • Obesity
  • Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

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
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcome Measures

Outcome Measure
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks

Collaborators and Investigators

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Italy, Greece, decresg@wyeth.com
  • Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com
  • Principal Investigator: Trial Manager, For Turkey, Erisc@wyeth.com
  • Principal Investigator: Trial manager, For Hungary, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For UK, ukmedonfo@wyeth.com
  • Principal Investigator: Trial Manager, For Norway, Sweden, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For Australia, Taiwan, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com

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

June 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0468H1-318
  • B1741188 (Other Identifier: Pfizer)

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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