EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
Information source: McGill University Health Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplant
Intervention: basiliximab (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: McGill University Health Center Official(s) and/or principal investigator(s):
jean tchervenkov, MD, Principal Investigator, Affiliation: Royal Victoria Hospital, Canada
Overall contact:
Jean Tchervenkov, MD, Phone: 514 934 1934, Ext: 33333, Email: tchervenkov@bell.blackberry.net
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
Secondary outcome: 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
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:
-
Locations and Contacts
Jean Tchervenkov, MD, Phone: 514 934 1934, Ext: 33333, Email: tchervenkov@bell.blackberry.net
MUHC Royal Victoria Hospital, Montreal, Quebec H3A 1A1, Canada; Not yet recruiting
Jean Tchervenkov, MD, Principal Investigator
Additional Information
Starting date: April 2007
Last updated: April 11, 2007
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