CClinicalTrials.gg
Status unknownNCT00302497Updated Apr 12, 2007

EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

A Phase 3 interventional study of basiliximab in Kidney Transplant, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-04-12.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2006), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Transplant
03

In context

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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:

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • Drugbasiliximab
06

What researchers measure

Primary outcomes

  1. To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.

Secondary outcomes

  1. 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.

07

Study locations

1 site
  • MUHC Royal Victoria Hospital
    Montreal, Quebec H3A 1A1, Canada
    • Jean Tchervenkov, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00302497
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted
Mar 14, 2006
Start date
Apr 2007
Completion
Apr 2008 (estimated)
Last update
Apr 12, 2007

Study contacts

Jean Tchervenkov, MD
Contact
tchervenkov@bell.blackberry.net
514 934 1934 ext. 33333
jean tchervenkov, MD
principal investigator · Royal Victoria Hospital, Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion