Status:
UNKNOWN
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Kidney Transplant
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
End Date :
April 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00302497
Start Date
April 1 2007
End Date
April 1 2008
Last Update
April 12 2007
Active Locations (1)
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1
MUHC Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1