EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

McGill University

Status and phase

Unknown

Phase 3

Conditions

Kidney Transplant

Treatments

Drug: basiliximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00302497

CCHI621ACA07

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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