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EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00302497
First received: March 10, 2006
Last updated: April 11, 2007
Last verified: February 2006
History of Changes
  Purpose

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 Intervention Phase
Kidney Transplant
 Drug: basiliximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

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

Further study details as provided by McGill University Health Center:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302497

Contacts
Contact: Jean Tchervenkov, MD 514 934 1934 ext 33333 tchervenkov@bell.blackberry.net

Locations
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
Investigators
Principal Investigator: jean tchervenkov, MD Royal Victoria Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00302497     History of Changes
Other Study ID Numbers: CCHI621ACA07
Study First Received: March 10, 2006
Last Updated: April 11, 2007
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013