EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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basiliximab

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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jean tchervenkov, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Hospital, Canada

Locations

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MUHC Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Jean Tchervenkov, MD

Role: CONTACT

[email protected]

514 934 1934 ext. 33333

Other Identifiers

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CCHI621ACA07

Identifier Type: -

Identifier Source: org_study_id