EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

Kidney Transplant Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00302497
• Other study ID #: CCHI621ACA07
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 10, 2006
• Last updated: April 11, 2007
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: February 2006
• Source: McGill University Health Center
• Contact: Jean Tchervenkov, MD
• Phone: 514 934 1934
• Email: tchervenkov[@]bell.blackberry.net
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• basiliximab

Locations

Country	Name	City	State
Canada	MUHC Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
Secondary	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.