EXTEND Protocol for Transplanted Patient to Evaluate Kidn... | NCT00302497

Studies
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

NCT00302497

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Status

Unknown status

Last Update Posted

Apr 12, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

Kidney Transplant

Interventions

basiliximab

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Estimated

First Submitted Date

Mar 10, 2006

First Submission Date that Met QC Criteria

Mar 10, 2006

First Posted Date

Mar 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2007

Last Update Posted Date

Apr 12, 2007Estimated

Description Module

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 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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
basiliximab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins