EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00302497
Recruitment Status : Unknown
Verified February 2006 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2006
Last Update Posted : April 12, 2007
Information provided by:
McGill University Health Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: basiliximab Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2007
Estimated Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab
U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00302497

Contact: Jean Tchervenkov, MD 514 934 1934 ext 33333

Canada, Quebec
MUHC Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: Jean Tchervenkov, MD         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: jean tchervenkov, MD Royal Victoria Hospital, Canada Identifier: NCT00302497     History of Changes
Other Study ID Numbers: CCHI621ACA07
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: April 12, 2007
Last Verified: February 2006

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs