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

March 10, 2006
April 11, 2007
April 2007
Not Provided
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
Same as current
Complete list of historical versions of study NCT00302497 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant
Drug: basiliximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
April 2008
Not Provided

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:

-

Both
40 Years to 75 Years
No
Contact: Jean Tchervenkov, MD 514 934 1934 ext 33333 tchervenkov@bell.blackberry.net
Canada
 
NCT00302497
CCHI621ACA07
Not Provided
Not Provided
McGill University Health Center
Not Provided
Principal Investigator: jean tchervenkov, MD Royal Victoria Hospital, Canada
McGill University Health Center
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP