EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

April 11, 2007 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

12 Month, Prospective, Randomised, Open-Label Comparative Study to Evaluate the Protection of Kidney Function by Basiliximab in a CNI-Free Regimen in Newly Kidney Transplanted Patients (Three Months Post-Transplant) Who Are Recipient of One Kidney From Expanded Donor Criteria (UNOS Criteria)

The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities.

This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • MUHC Royal Victoria Hospital

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

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female patients aged 40 to 75 years with a viable graft
  • patients who are recipients of a primary or secondary graft from a cadaveric expanded donor criteria
  • patients who had no change of immunosuppressor two weeks prior to baseline
  • patients who had no acute rejection four weeks prior to baseline
  • patients who are willing and capable of giving written informed consent for study participation
  • females of childbearing potential must have a negative serum pregnancy test within 7 days prior to baseline.Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility
  • Patients who are HCV and HBV negative

Exclusion Criteria

  • patients who have a calculated GFR (Nankivell formula) of less than 30mL/min at baseline
  • Patients who are recipients of multiple organ transplants
  • Patients who are recipients of dual kidney transplants
  • Patients with panel reactive antibodies >50% at transplant
  • Patients with a known hypersensitivity to tacrolimus,EC-MPS or basiliximab at baseline
  • Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
  • Patients who are HIV positive at study entry
  • Patients who have received a kidney from a HCV positive or HBV positive donor
  • Patients with signs of active immune process on graft biopsy at baseline
  • Patients with polyoma (BK or JC)
  • Patients with operative or technical failure

Exclusion Criteria:

-

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: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.

Secondary Outcome Measures

Outcome Measure
To demonstrate that the efficacy of basiliximab compared to the efficacy of tacrolimus kis comparable in the prevention of acute cellular rejection at 3 and 12 months after baseline.

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: jean tchervenkov, MD, Royal Victoria Hospital, Canada

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, 2007

Study Completion (ANTICIPATED)

April 1, 2008

Study Registration Dates

First Submitted

March 10, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (ESTIMATE)

March 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 12, 2007

Last Update Submitted That Met QC Criteria

April 11, 2007

Last Verified

February 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHI621ACA07

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.

Subscribe